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The positive effect of negative pressure: vacuum-assisted fixation of Integra artificial skin for reconstructive surgery
Journal of Pediatric Surgery (2009) 44, 575–580
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The positive effect of negative pressure: vacuum-assisted fixation of Integra artificial skin for reconstructive surgery Dorothea Stiefel ⁎, Clemens M. Schiestl, Martin Meuli Pediatric Burn Center, Plastic and Reconstructive Surgery, Department of Surgery, University Children's Hospital Zurich, CH-8032 Zurich, Switzerland Received 13 December 2007; revised 26 June 2008; accepted 2 July 2008
Key words: Vacuum-assisted closure system; Negative pressure; Reconstructive surgery; Pediatric patients; Integra artificial skin; Skin substitute
Abstract Background: Integra artificial skin (Integra) (Integra Life Sciences Corporation, Plainsboro, NJ) is increasingly used as a skin substitute in reconstructive surgery. However, reliable fixation to the wound bed, a factor of paramount importance for successful application, is often hard to achieve. The vacuumassisted closure system (VAC; KCI, Switzerland), a well-established subatmospheric pressure device, might be of interest to overcome these problems because of its ability to conform to almost any surface. The goal of this study was to test whether negative pressure application yields reliable fixation of Integra in children undergoing reconstructive surgery. Methods: Between 2001 and 2004, VAC was applied in 18 children (n = 18) aged 7 months to 16.5 years. All required reconstructive surgery with implantation of Integra covering 1% to 12% of the total body surface area. After Integra implantation, VAC was installed for 13 to 30 days. Results: The VAC fixation of Integra was successful in 17 patients (94.5%). The only failure (5.5%) occurred in a patient in whom negative pressure could not be maintained because of a lesion site susceptible to both dislodgement and infection (perianal region). Consequently, infection occurred, and Integra had to be removed. Conclusions: These results demonstrate that VAC is a valid tool for reliable fixation of Integra in children undergoing even demanding reconstructive surgery. © 2009 Elsevier Inc. All rights reserved.
Integra artificial skin (Integra) (Integra Life Sciences Corporation, Plainsboro, NJ, U.S.A.) was clinically introduced by Burke [1] in 1981 as a biosynthetic skin substitute. Meanwhile, it is well established and widely used in the management of large acute burns [2]. It is also applied, however, to a significantly lesser extent, in reconstructive surgery [3] aiming at optimizing both functional and cosmetic outcomes. For a successful use of Integra, it is ⁎ Corresponding author. E-mail address: [email protected] (D. Stiefel). 0022-3468/$ – see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2008.07.006
paramount to achieve sufficient, that is, ubiquitous, firm, and continuous adherence to the wound bed because only then correct incorporation of this dermal regeneration template can occur properly [4,5]. The indispensable intimate contact, however, may be difficult or impossible to achieve, especially on irregular or concave body contours and in small children in whom constant and appropriate immobilization is often difficult or impossible. We hypothesized that the vacuum-assisted closure system [5-7] (VAC; KCI, Switzerland) might be a suitable fixation tool to achieve adherence properties as described above both
576
D. Stiefel et al.
in notoriously difficult locations and in potentially problematic patients. VAC was introduced by Argenta [8] in 1997 to enhance chronic wound closure and was shortly thereafter advocated as fixation device for split-thickness skin grafts (STSG) in adults [9]. Briefly, it consists of a sterile polyurethane ether sponge that is placed on the body area to be treated, then tightly sealed with a self-adhesive plastic sheet and connected to an evacuation pump with subatmospheric pressure. The open-cell nature of the sponge ensures equal distribution of the applied vacuum throughout the collapsing foam, leading thereby to evenly exerted pressure of the sponge against the underlying surface. At the same time, secretion from the wound bed is continuously evacuated while edema and bacterial contamination seem to decrease and local blood flow to improve [5]. The goal of our study was to test whether VAC can be safely and efficiently used for reliable fixation of Integra in pediatric patients undergoing reconstructive surgery.
1. Patients and methods Patients' data are given in Table 1. VAC was used for fixation of Integra in 18 children (n = 18) aged 7 months to 16.5 years (mean, 7.6 years; male-female ratio = 1:3) requiring reconstructive surgery from November 2001 until November 2004. Locations included shoulder, upper and Table 1
lower limbs, trunk, and perineal region encompassing a total body surface area of 1% to 12% (mean, 3.7%; Figs. 1A, 2A, 3A). Surgery was performed at the same institution and always by the same team of 2 to 3 experienced pediatric surgeons. After complete excision of the hypertrophic scar, hamartoma, or nevus (mostly full-thickness excision down to subcutaneous fat) and meticulous hemostasis, defects were immediately covered with unmeshed Integra, prepared according to standard protocols (Fig. 1B). The implant was affixed to the wound bed with fibrin glue (Tissucol kit; Baxter) and additionally secured with single stitches or running sutures at the edges. The sponge of the VAC was directly placed and close-fitted onto the silicone layer of Integra. The adjacent skin was protected with stripes of a hydrocolloid tape. The sponge was covered with an adherent plastic drape extending onto the adjacent skin, thus creating an airtight seal over the entire area. Continuous subatmospheric pressure of 100 to 125 mm Hg was installed with a portable evacuation pump run either with rechargeable batteries or with electricity from the socket (Figs. 1C, 2B, 3B). To closely monitor possible infection under the Integra, pertinent clinical symptoms including body temperature, pain and increased secretion, as well as C-reactive protein and leukocyte counts, were checked regularly. When signs of infection were absent, dressing changes were performed at weekly intervals, usually under general anesthesia, starting at day 5 postimplantation. VAC was usually applied for 3 weeks. Thereafter, and if
Overview of pertinent patient data and results of VAC-assisted Integra fixation
Patient no.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Mean values
Sex
Female Female Male Female Female Male Male Female Female Female Female Female Female Female Female Female Male Female
Age (mo, y)
Lesion indication
Site TBSA%
Successful VAC application
Complication
7 mo 7 mo 9 mo 1 6/12 y 2 3/12 y 2 5/12 y 3 3/12 y 3 6/12 y 8 2/12 y 9 8/12y 10 2/12 y 12 8/12 y 13 6/12 y 13 6/12 y 14 3/12 y 14 5/12 y 15y 16 6/12 y 7.6 y
CGMN shoulder Hamartoma leg CGMN trunk CGMN trunk CGMN arm CGMN leg CGMN arm CGMN buttock HS leg CGMN buttock HS trunk HS leg HS leg HS arm HS leg HS trunk HS arm HS leg
2 5 12 6 4 3 3 10 1 4 1 2 3 3 2 1 3 1 3.7%
+ + + + + + + − + + + + + + + + + + 94.5%
Nonintegration
Infection Infection Infection
Seroma
Seroma 33.3%
Integra take %
Skin graft Day
STSG take %
0/100 a 100 97 70/100 a 95 0/100 a 100 50/30 a 100 100 100 100 100 100 100 100 95 100 84%/95% b
−/19 21 15 −/21 16 −/15 21 −/30 21 20 26 21 20 25 13 25 30 28 21.4d
95 100 95 95 95 100 100 100 100 100 100 100 95 100 90 80 100 100 97%
CGMN, congenital giant melanocytic nevus; HS, hypertrophic scar; TBSA, total body surface area. a Patients with 2 consecutive Integra applications owing to complications; take rates are given separately for each procedure. b The first number (84%) gives the mean value of all 18 patients after the first Integra application. The second number (95%) gives the mean value of all 18 patients, including now take rates of the second application in those patients who needed a redo (patient no. 1, 4, 6, 8).
Vacuum-assisted fixation of Integra artificial skin for reconstructive surgery
577
Fig. 1 Illustrative photographic sequence of a typical reconstructive surgical procedure. A, Preoperative documentation of a hypertrophic scar resting on the knee cap (patient no. 12). B, After total excision of the lesion, the almost transparent Integra (i) is placed onto the wound bed and secured along the edges with a running suture (s). The adjacent skin is protected with stripes of a hydrocolloid tape (t). At this point, the sponge (sp) is placed over the Integra and will be covered with a self-adherent plastic drape extending onto the adjacent skin, thus creating an airtight seal over the entire area. C, A plastic tube connects the sealed area with the vacuum pump. Continuous subatmospheric pressure of 100 to 125 mm Hg is installed over the lesion. D, Lateral view of the lesion 3 weeks after Integra implantation and before removal of the silicone layer. Note the peach color of the neodermis indicating sufficient vascularization. E, Postoperative evaluation 1 year later. Overall, a very satisfactory result with an Integra-derived neo-skin closely resembling normal skin both in functional and cosmetic terms.
Integra demonstrated solid incorporation and sufficient vascularization as reflected by a peach color appearance (Figs. 1D and 3C), the silicone layer was removed, take rate was recorded as a percentage of the area treated, and the neodermis was covered with an unmeshed thin STSG (0.1-0.2 mm) harvested from the scalp. The first dressing change was performed 5 days postgrafting, and autograft take rate was noted as a percentage of the area grafted. This standard procedure was applied in all but one patient (no. 10). Here, the procedure was extended with preoperative colonic washouts, a refined intraoperative sealing technique, perioperative antibiotics, and postoperative parenteral nutrition. With all wounds closed, a standard rehabilitation and scar prevention regimen was installed—including specific skin care, pressure
garments, contact media, splinting, occupational therapy, and physiotherapy—until the grafted skin was completely mature (Figs. 1E, 2D, 3D).
2. Results An overview of results, complications, and other pertinent aspects is provided in Table 1. VAC was applied in 18 pediatric patients (n = 18 = 100%) requiring plastic or reconstructive surgery with the aim to fix Integra properly. Technically, VAC was applied successfully in 17 (94.5%) of 18 patients. In particular, there were no noteworthy problems
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D. Stiefel et al.
Fig. 2 A to D show the buttocks of a 3 6/12-year-old girl in whom VAC application failed (patient no. 8). Thus, Integra had to be applied twice because of infection with take rates of 50% (first application) and 30% (second application). Eventually, the lesion had to be covered for most parts with STSG alone. A, Preoperative documentation. Note that the dark, hairy, and flat nevus was previously reduced in size (expander technique and partial excision seen as scars along the edges of the lesion). B, The sponge of the VAC is in place. Two tubes are connected with the airtight seal, and subatmospheric pressure has been installed. Note the possibly occurring difficulty to maintain the airtight seal along the rima ani. C, Result 1 week after the first Integra implantation. Note the signs of infection under the silicone layer (inf). On the right buttock and in the rima ani, the silicone layer already has been removed (white dotted line). D, Postoperative evaluation 3 years later. This long-term result is considered very good, especially in view of the serious complications incurred.
regarding establishment and maintenance of negative pressure. The only case (5.5%) where VAC application failed was the first patient with reconstructive surgery in the gluteal-perianal region (patient no. 8; Figs. 2A-D). Because of repetitive loss of negative pressure and despite of appropriate repair maneuvers, Integra became stool contaminated and finally had to be removed because of infection. After adequate wound treatment, Integra was applied again, with a final take rate of 30%. Eventually, the lesion was successfully closed with STSG with a take of 100%. Notably, the second patient (no. 10; Figs. 3A-D) also requiring gluteal-perianal surgery was given the aforementioned extended perioperative management and had an uneventful course. Complication rate in this series was 33% including nonintegration of Integra in 1 (5.5%) and infection in 3 patients (16.5%), both considered as major complications. Seroma formation in 2 patients (11%) was considered as minor complication. In the 14 patients with primarily uneventful Integra implantation, take rate of Integra ranged from 95% to 100% (mean, 99%). In the 4 patients in whom
Integra had to be applied twice, take rate after the first application ranged from 0% to 70% (mean, 30%) and from 30% to 100% after the second application (mean, 82.5%). Therefore, the mean take rate of Integra in all 18 patients was 84% after the first application and 95% if take rates of the primarily successful patients are added up to the second Integra application of the 4 failing patients respectively (see Table 1). Take rates of STSG ranged from 80% to 100% (mean, 97%). Three patients (no. 1, 6, and 8) needed complete and 1 patient (no. 4) partial replacement of Integra. In 3 of these patients, Integra loss was unrelated to VAC application difficulties. It occurred because of infection in 2 (no. 4 and 6) and nonintegration in 1 (no. 1) patient. After the second implantation, all these patients showed an uneventful course. Generally, patients were hospitalized during the entire 2stage procedure. Two older patients (no. 11 and 17), deemed particularly coachable and compliant, were allowed to go home with the portable vacuum pump after 10 days of an unremarkable course in hospital. At outpatient follow-
Vacuum-assisted fixation of Integra artificial skin for reconstructive surgery
579
Fig. 3 A to D show the right buttock of a 9 8/12-year-old girl in whom VAC application was successful (patient no. 10). Here, a much more sophisticated regimen including preoperative colonic washouts, a refined intraoperative sealing technique, perioperative antibiotics, and postoperative parenteral nutrition was used as compared to the patient in Fig. 2. A, Preoperative documentation. The lesion is dark, flat, hairy, and shows sharp contours. A few satellite nevi are present. B, The sponge of the VAC is in place and sealed off under the plastic sheet. One tube is connecting the lesion with the vacuum pump. Note that meticulous sealing technique has been applied to create an airtight seal and maintain continuous subatmospheric pressure for 3 weeks. C, Result 3 weeks after Integra implantation. No signs of infection are apparent, but the peach color of the neodermis underneath the transparent silicone layer still in situ. D, Postoperative evaluation 6 months postoperatively. A fairly mature scar with soft and pliable skin.
up, however, both patients showed seromas under the Integra (2 × 2 cm and 5 × 5 cm, respectively) requiring readmission, seroma evacuation, and bed rest. The further course was uneventful.
3. Discussion This study generates convincing evidence that VAC can be used efficiently and safely to fix Integra firmly for a period of 3 weeks. During this time, Integra becomes incorporated into the wound bed and is transformed into a neodermis so that the second step of the procedure, that is, grafting of an ultrathin STSG, can be performed successfully. VAC was applied without any system-related technical or handling problems in most (94.5%) of our pediatric patients. Regardless of the patient's age, location, or size of the lesion, establishment and continuous maintenance of negative pressure over the implant was easily feasible and apparently facilitated incorporation of the dermal implant. The impress-
ively high success rate is particularly relevant because it was obtained in a purely pediatric series. No doubt, compared to adults, infants and children are much more at risk for Integra loss because they cannot understand and comply with instructions directed at Integra protection. Generally speaking, pediatric patients deserve a much more generous indication for VAC than adults, especially when uneven surfaces involved with motion are concerned. In our study, grafting was usually scheduled 3 weeks after implantation as recommended by the manufacturer and some authors [10-12]. From clinical judgment, and in contrast to some reports [5,7], we did not find any evidence that VAC application significantly accelerated vascularization of Integra so as to allow earlier grafting. In our experience, it always takes just about 3 weeks for the desired peach color to develop, independent from whether VAC was applied or not. The only real VAC failure was noted in a particularly difficult case of a gluteal-perianal reconstruction during the learning curve period of the study. Importantly, a subsequent and fairly identical case was managed under a much more
580 sophisticated perioperative regimen without complications. Although purely empirical, it is reasonable to assume that preoperative colonic washouts, a most meticulous intraoperative sealing technique, perioperative antibiotics, postoperative prone position, and parenteral nutrition for the first 2 to 3 postoperative weeks are effective measures to prevent infection. We are currently performing quite successfully all sorts of emergency (especially burns) and elective grafting procedures in this notoriously delicate area under the above described precautions. The other difficulties encountered were clearly not associated to VAC. The major complications leading to partial loss of Integra (infection, nonintegration of the product) as well as seroma formation should rather be seen in the context of the well-known problems specifically related to the application of Integra [5,10,11]. At this early time-point, it is difficult to figure out whether fixation of Integra with VAC is a better choice than traditional dressing techniques because there are no comparative studies available. Clearly, simple or tie-over dressings as well as dressings with bolsters or pads have limitations, especially with regard to shearing known to jeopardize proper incorporation of Integra [4,6]. On the other hand, our preliminary experience suggests that VAC does offer some relevant advantages over current modalities [6]. It seems to be an optimal device to force the rather rigid dermal template to close-fit to almost any, in particular to concave and circumferential, body contours. Moreover, the collapsed sponge stiffens and acts thereby as a splint reinforcing immobilization of the area, an effect particularly welcome in babies and infants too small to understand and obey instructions. Finally, continuous suction evacuates wound secretion and blood instantly, at least from the wound edges, thereby lowering the risk of seroma, hematoma, and infection. Finally, options to reduce the extremely high cost of the procedures reported on here (Integra + Tissucol + VAC + long hospitalization) must be discussed. For instance, in areas with low risk of complications, such as upper and lower limb, VAC needs to be evaluated and weighed carefully against traditional techniques such as tie-over dressings. Moreover, portable battery-operated aspirators can be used,
D. Stiefel et al. so that patients are not confined to bed and can even be treated (at least partly) as outpatients. These steps reduce nursing time, hospital stay, and thus cost. In conclusion, this is the first report on a larger series of children requiring demanding reconstructive surgical procedures to demonstrate the value of VAC to secure Integra reliably and safely to the wound bed for the required period.
References [1] Burke JF, Yannas IV, Jung WK, et al. Successful use of a physiologically acceptable artificial skin in the treatment of extensive burn injury. Ann Surg 1981;194:413-28. [2] Heimbach D, Luterman A, Zawacki B, et al. Artificial dermis for major burns: a multi-center randomized clinical trial. Ann Surg 1988;208: 313-20. [3] Moiemen NS, Staiano JJ, Frame JD, et al. Reconstructive surgery with a dermal regeneration template: clinical and histologic study. Plast Reconstr Surg 2001;108:93-103. [4] Schneider AM, Morykwas MJ, Argenta LC. A new and reliable method of securing skin grafts to the difficult recipient bed. Plast Reconstr Surg 1998;102:1195-8. [5] Molnar JA, DeFranzo AJ, Argenta LC, et al. Acceleration of Integra incorporation in complex tissue defects with subatmospheric pressure. Plast Reconstr Surg 2004;113:1339-46. [6] McEwan W, Brown TLH, Muller MJ, et al. Suction dressings to secure a dermal substitute. Burns 2004;30:259-61. [7] Jeschke MG, Rose C, Bolder U, et al. Development of new reconstructive techniques: use of Integra in combination with fibrin glue and negative-pressure therapy for reconstruction of acute and chronic wounds. Plast Reconstr Surg 2004;113:525-30. [8] Argenta LC, Morykwas MJ. Vacuum-assisted closure. A new method for wound control and treatment: clinical experience. Ann Plast Surg 1997;38(6):563-77. [9] Blackburn II JH, Boemi L, Graham III WP, et al. Negative-pressure dressings as a bolster for skin grafts. Ann Plast Surg 1998;40(5):453-7. [10] Dantzer E, Braye FM. Reconstructive surgery using artificial dermis (Integra): results with 39 grafts. Br J Plast Surg 2001;54:659-64. [11] Heimbach D, Warden G, Dimick AR, et al. Multicenter postapproval clinical trial of IntegraÒ dermal regeneration template for burn treatment. J Burn Care Rehabil 2003;24/1:42-8. [12] Moiemen NS, Vlachou E, Frame JD, et al. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg 2006;117(7): 160-74.
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The positive effect of negative pressure: vacuum-assisted fixation of Integra artificial skin for reconstructive surgery Dorothea Stiefel ⁎, Clemens M. Schiestl, Martin Meuli Pediatric Burn Center, Plastic and Reconstructive Surgery, Department of Surgery, University Children's Hospital Zurich, CH-8032 Zurich, Switzerland Received 13 December 2007; revised 26 June 2008; accepted 2 July 2008
Key words: Vacuum-assisted closure system; Negative pressure; Reconstructive surgery; Pediatric patients; Integra artificial skin; Skin substitute
Abstract Background: Integra artificial skin (Integra) (Integra Life Sciences Corporation, Plainsboro, NJ) is increasingly used as a skin substitute in reconstructive surgery. However, reliable fixation to the wound bed, a factor of paramount importance for successful application, is often hard to achieve. The vacuumassisted closure system (VAC; KCI, Switzerland), a well-established subatmospheric pressure device, might be of interest to overcome these problems because of its ability to conform to almost any surface. The goal of this study was to test whether negative pressure application yields reliable fixation of Integra in children undergoing reconstructive surgery. Methods: Between 2001 and 2004, VAC was applied in 18 children (n = 18) aged 7 months to 16.5 years. All required reconstructive surgery with implantation of Integra covering 1% to 12% of the total body surface area. After Integra implantation, VAC was installed for 13 to 30 days. Results: The VAC fixation of Integra was successful in 17 patients (94.5%). The only failure (5.5%) occurred in a patient in whom negative pressure could not be maintained because of a lesion site susceptible to both dislodgement and infection (perianal region). Consequently, infection occurred, and Integra had to be removed. Conclusions: These results demonstrate that VAC is a valid tool for reliable fixation of Integra in children undergoing even demanding reconstructive surgery. © 2009 Elsevier Inc. All rights reserved.
Integra artificial skin (Integra) (Integra Life Sciences Corporation, Plainsboro, NJ, U.S.A.) was clinically introduced by Burke [1] in 1981 as a biosynthetic skin substitute. Meanwhile, it is well established and widely used in the management of large acute burns [2]. It is also applied, however, to a significantly lesser extent, in reconstructive surgery [3] aiming at optimizing both functional and cosmetic outcomes. For a successful use of Integra, it is ⁎ Corresponding author. E-mail address: [email protected] (D. Stiefel). 0022-3468/$ – see front matter © 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2008.07.006
paramount to achieve sufficient, that is, ubiquitous, firm, and continuous adherence to the wound bed because only then correct incorporation of this dermal regeneration template can occur properly [4,5]. The indispensable intimate contact, however, may be difficult or impossible to achieve, especially on irregular or concave body contours and in small children in whom constant and appropriate immobilization is often difficult or impossible. We hypothesized that the vacuum-assisted closure system [5-7] (VAC; KCI, Switzerland) might be a suitable fixation tool to achieve adherence properties as described above both
576
D. Stiefel et al.
in notoriously difficult locations and in potentially problematic patients. VAC was introduced by Argenta [8] in 1997 to enhance chronic wound closure and was shortly thereafter advocated as fixation device for split-thickness skin grafts (STSG) in adults [9]. Briefly, it consists of a sterile polyurethane ether sponge that is placed on the body area to be treated, then tightly sealed with a self-adhesive plastic sheet and connected to an evacuation pump with subatmospheric pressure. The open-cell nature of the sponge ensures equal distribution of the applied vacuum throughout the collapsing foam, leading thereby to evenly exerted pressure of the sponge against the underlying surface. At the same time, secretion from the wound bed is continuously evacuated while edema and bacterial contamination seem to decrease and local blood flow to improve [5]. The goal of our study was to test whether VAC can be safely and efficiently used for reliable fixation of Integra in pediatric patients undergoing reconstructive surgery.
1. Patients and methods Patients' data are given in Table 1. VAC was used for fixation of Integra in 18 children (n = 18) aged 7 months to 16.5 years (mean, 7.6 years; male-female ratio = 1:3) requiring reconstructive surgery from November 2001 until November 2004. Locations included shoulder, upper and Table 1
lower limbs, trunk, and perineal region encompassing a total body surface area of 1% to 12% (mean, 3.7%; Figs. 1A, 2A, 3A). Surgery was performed at the same institution and always by the same team of 2 to 3 experienced pediatric surgeons. After complete excision of the hypertrophic scar, hamartoma, or nevus (mostly full-thickness excision down to subcutaneous fat) and meticulous hemostasis, defects were immediately covered with unmeshed Integra, prepared according to standard protocols (Fig. 1B). The implant was affixed to the wound bed with fibrin glue (Tissucol kit; Baxter) and additionally secured with single stitches or running sutures at the edges. The sponge of the VAC was directly placed and close-fitted onto the silicone layer of Integra. The adjacent skin was protected with stripes of a hydrocolloid tape. The sponge was covered with an adherent plastic drape extending onto the adjacent skin, thus creating an airtight seal over the entire area. Continuous subatmospheric pressure of 100 to 125 mm Hg was installed with a portable evacuation pump run either with rechargeable batteries or with electricity from the socket (Figs. 1C, 2B, 3B). To closely monitor possible infection under the Integra, pertinent clinical symptoms including body temperature, pain and increased secretion, as well as C-reactive protein and leukocyte counts, were checked regularly. When signs of infection were absent, dressing changes were performed at weekly intervals, usually under general anesthesia, starting at day 5 postimplantation. VAC was usually applied for 3 weeks. Thereafter, and if
Overview of pertinent patient data and results of VAC-assisted Integra fixation
Patient no.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Mean values
Sex
Female Female Male Female Female Male Male Female Female Female Female Female Female Female Female Female Male Female
Age (mo, y)
Lesion indication
Site TBSA%
Successful VAC application
Complication
7 mo 7 mo 9 mo 1 6/12 y 2 3/12 y 2 5/12 y 3 3/12 y 3 6/12 y 8 2/12 y 9 8/12y 10 2/12 y 12 8/12 y 13 6/12 y 13 6/12 y 14 3/12 y 14 5/12 y 15y 16 6/12 y 7.6 y
CGMN shoulder Hamartoma leg CGMN trunk CGMN trunk CGMN arm CGMN leg CGMN arm CGMN buttock HS leg CGMN buttock HS trunk HS leg HS leg HS arm HS leg HS trunk HS arm HS leg
2 5 12 6 4 3 3 10 1 4 1 2 3 3 2 1 3 1 3.7%
+ + + + + + + − + + + + + + + + + + 94.5%
Nonintegration
Infection Infection Infection
Seroma
Seroma 33.3%
Integra take %
Skin graft Day
STSG take %
0/100 a 100 97 70/100 a 95 0/100 a 100 50/30 a 100 100 100 100 100 100 100 100 95 100 84%/95% b
−/19 21 15 −/21 16 −/15 21 −/30 21 20 26 21 20 25 13 25 30 28 21.4d
95 100 95 95 95 100 100 100 100 100 100 100 95 100 90 80 100 100 97%
CGMN, congenital giant melanocytic nevus; HS, hypertrophic scar; TBSA, total body surface area. a Patients with 2 consecutive Integra applications owing to complications; take rates are given separately for each procedure. b The first number (84%) gives the mean value of all 18 patients after the first Integra application. The second number (95%) gives the mean value of all 18 patients, including now take rates of the second application in those patients who needed a redo (patient no. 1, 4, 6, 8).
Vacuum-assisted fixation of Integra artificial skin for reconstructive surgery
577
Fig. 1 Illustrative photographic sequence of a typical reconstructive surgical procedure. A, Preoperative documentation of a hypertrophic scar resting on the knee cap (patient no. 12). B, After total excision of the lesion, the almost transparent Integra (i) is placed onto the wound bed and secured along the edges with a running suture (s). The adjacent skin is protected with stripes of a hydrocolloid tape (t). At this point, the sponge (sp) is placed over the Integra and will be covered with a self-adherent plastic drape extending onto the adjacent skin, thus creating an airtight seal over the entire area. C, A plastic tube connects the sealed area with the vacuum pump. Continuous subatmospheric pressure of 100 to 125 mm Hg is installed over the lesion. D, Lateral view of the lesion 3 weeks after Integra implantation and before removal of the silicone layer. Note the peach color of the neodermis indicating sufficient vascularization. E, Postoperative evaluation 1 year later. Overall, a very satisfactory result with an Integra-derived neo-skin closely resembling normal skin both in functional and cosmetic terms.
Integra demonstrated solid incorporation and sufficient vascularization as reflected by a peach color appearance (Figs. 1D and 3C), the silicone layer was removed, take rate was recorded as a percentage of the area treated, and the neodermis was covered with an unmeshed thin STSG (0.1-0.2 mm) harvested from the scalp. The first dressing change was performed 5 days postgrafting, and autograft take rate was noted as a percentage of the area grafted. This standard procedure was applied in all but one patient (no. 10). Here, the procedure was extended with preoperative colonic washouts, a refined intraoperative sealing technique, perioperative antibiotics, and postoperative parenteral nutrition. With all wounds closed, a standard rehabilitation and scar prevention regimen was installed—including specific skin care, pressure
garments, contact media, splinting, occupational therapy, and physiotherapy—until the grafted skin was completely mature (Figs. 1E, 2D, 3D).
2. Results An overview of results, complications, and other pertinent aspects is provided in Table 1. VAC was applied in 18 pediatric patients (n = 18 = 100%) requiring plastic or reconstructive surgery with the aim to fix Integra properly. Technically, VAC was applied successfully in 17 (94.5%) of 18 patients. In particular, there were no noteworthy problems
578
D. Stiefel et al.
Fig. 2 A to D show the buttocks of a 3 6/12-year-old girl in whom VAC application failed (patient no. 8). Thus, Integra had to be applied twice because of infection with take rates of 50% (first application) and 30% (second application). Eventually, the lesion had to be covered for most parts with STSG alone. A, Preoperative documentation. Note that the dark, hairy, and flat nevus was previously reduced in size (expander technique and partial excision seen as scars along the edges of the lesion). B, The sponge of the VAC is in place. Two tubes are connected with the airtight seal, and subatmospheric pressure has been installed. Note the possibly occurring difficulty to maintain the airtight seal along the rima ani. C, Result 1 week after the first Integra implantation. Note the signs of infection under the silicone layer (inf). On the right buttock and in the rima ani, the silicone layer already has been removed (white dotted line). D, Postoperative evaluation 3 years later. This long-term result is considered very good, especially in view of the serious complications incurred.
regarding establishment and maintenance of negative pressure. The only case (5.5%) where VAC application failed was the first patient with reconstructive surgery in the gluteal-perianal region (patient no. 8; Figs. 2A-D). Because of repetitive loss of negative pressure and despite of appropriate repair maneuvers, Integra became stool contaminated and finally had to be removed because of infection. After adequate wound treatment, Integra was applied again, with a final take rate of 30%. Eventually, the lesion was successfully closed with STSG with a take of 100%. Notably, the second patient (no. 10; Figs. 3A-D) also requiring gluteal-perianal surgery was given the aforementioned extended perioperative management and had an uneventful course. Complication rate in this series was 33% including nonintegration of Integra in 1 (5.5%) and infection in 3 patients (16.5%), both considered as major complications. Seroma formation in 2 patients (11%) was considered as minor complication. In the 14 patients with primarily uneventful Integra implantation, take rate of Integra ranged from 95% to 100% (mean, 99%). In the 4 patients in whom
Integra had to be applied twice, take rate after the first application ranged from 0% to 70% (mean, 30%) and from 30% to 100% after the second application (mean, 82.5%). Therefore, the mean take rate of Integra in all 18 patients was 84% after the first application and 95% if take rates of the primarily successful patients are added up to the second Integra application of the 4 failing patients respectively (see Table 1). Take rates of STSG ranged from 80% to 100% (mean, 97%). Three patients (no. 1, 6, and 8) needed complete and 1 patient (no. 4) partial replacement of Integra. In 3 of these patients, Integra loss was unrelated to VAC application difficulties. It occurred because of infection in 2 (no. 4 and 6) and nonintegration in 1 (no. 1) patient. After the second implantation, all these patients showed an uneventful course. Generally, patients were hospitalized during the entire 2stage procedure. Two older patients (no. 11 and 17), deemed particularly coachable and compliant, were allowed to go home with the portable vacuum pump after 10 days of an unremarkable course in hospital. At outpatient follow-
Vacuum-assisted fixation of Integra artificial skin for reconstructive surgery
579
Fig. 3 A to D show the right buttock of a 9 8/12-year-old girl in whom VAC application was successful (patient no. 10). Here, a much more sophisticated regimen including preoperative colonic washouts, a refined intraoperative sealing technique, perioperative antibiotics, and postoperative parenteral nutrition was used as compared to the patient in Fig. 2. A, Preoperative documentation. The lesion is dark, flat, hairy, and shows sharp contours. A few satellite nevi are present. B, The sponge of the VAC is in place and sealed off under the plastic sheet. One tube is connecting the lesion with the vacuum pump. Note that meticulous sealing technique has been applied to create an airtight seal and maintain continuous subatmospheric pressure for 3 weeks. C, Result 3 weeks after Integra implantation. No signs of infection are apparent, but the peach color of the neodermis underneath the transparent silicone layer still in situ. D, Postoperative evaluation 6 months postoperatively. A fairly mature scar with soft and pliable skin.
up, however, both patients showed seromas under the Integra (2 × 2 cm and 5 × 5 cm, respectively) requiring readmission, seroma evacuation, and bed rest. The further course was uneventful.
3. Discussion This study generates convincing evidence that VAC can be used efficiently and safely to fix Integra firmly for a period of 3 weeks. During this time, Integra becomes incorporated into the wound bed and is transformed into a neodermis so that the second step of the procedure, that is, grafting of an ultrathin STSG, can be performed successfully. VAC was applied without any system-related technical or handling problems in most (94.5%) of our pediatric patients. Regardless of the patient's age, location, or size of the lesion, establishment and continuous maintenance of negative pressure over the implant was easily feasible and apparently facilitated incorporation of the dermal implant. The impress-
ively high success rate is particularly relevant because it was obtained in a purely pediatric series. No doubt, compared to adults, infants and children are much more at risk for Integra loss because they cannot understand and comply with instructions directed at Integra protection. Generally speaking, pediatric patients deserve a much more generous indication for VAC than adults, especially when uneven surfaces involved with motion are concerned. In our study, grafting was usually scheduled 3 weeks after implantation as recommended by the manufacturer and some authors [10-12]. From clinical judgment, and in contrast to some reports [5,7], we did not find any evidence that VAC application significantly accelerated vascularization of Integra so as to allow earlier grafting. In our experience, it always takes just about 3 weeks for the desired peach color to develop, independent from whether VAC was applied or not. The only real VAC failure was noted in a particularly difficult case of a gluteal-perianal reconstruction during the learning curve period of the study. Importantly, a subsequent and fairly identical case was managed under a much more
580 sophisticated perioperative regimen without complications. Although purely empirical, it is reasonable to assume that preoperative colonic washouts, a most meticulous intraoperative sealing technique, perioperative antibiotics, postoperative prone position, and parenteral nutrition for the first 2 to 3 postoperative weeks are effective measures to prevent infection. We are currently performing quite successfully all sorts of emergency (especially burns) and elective grafting procedures in this notoriously delicate area under the above described precautions. The other difficulties encountered were clearly not associated to VAC. The major complications leading to partial loss of Integra (infection, nonintegration of the product) as well as seroma formation should rather be seen in the context of the well-known problems specifically related to the application of Integra [5,10,11]. At this early time-point, it is difficult to figure out whether fixation of Integra with VAC is a better choice than traditional dressing techniques because there are no comparative studies available. Clearly, simple or tie-over dressings as well as dressings with bolsters or pads have limitations, especially with regard to shearing known to jeopardize proper incorporation of Integra [4,6]. On the other hand, our preliminary experience suggests that VAC does offer some relevant advantages over current modalities [6]. It seems to be an optimal device to force the rather rigid dermal template to close-fit to almost any, in particular to concave and circumferential, body contours. Moreover, the collapsed sponge stiffens and acts thereby as a splint reinforcing immobilization of the area, an effect particularly welcome in babies and infants too small to understand and obey instructions. Finally, continuous suction evacuates wound secretion and blood instantly, at least from the wound edges, thereby lowering the risk of seroma, hematoma, and infection. Finally, options to reduce the extremely high cost of the procedures reported on here (Integra + Tissucol + VAC + long hospitalization) must be discussed. For instance, in areas with low risk of complications, such as upper and lower limb, VAC needs to be evaluated and weighed carefully against traditional techniques such as tie-over dressings. Moreover, portable battery-operated aspirators can be used,
D. Stiefel et al. so that patients are not confined to bed and can even be treated (at least partly) as outpatients. These steps reduce nursing time, hospital stay, and thus cost. In conclusion, this is the first report on a larger series of children requiring demanding reconstructive surgical procedures to demonstrate the value of VAC to secure Integra reliably and safely to the wound bed for the required period.
References [1] Burke JF, Yannas IV, Jung WK, et al. Successful use of a physiologically acceptable artificial skin in the treatment of extensive burn injury. Ann Surg 1981;194:413-28. [2] Heimbach D, Luterman A, Zawacki B, et al. Artificial dermis for major burns: a multi-center randomized clinical trial. Ann Surg 1988;208: 313-20. [3] Moiemen NS, Staiano JJ, Frame JD, et al. Reconstructive surgery with a dermal regeneration template: clinical and histologic study. Plast Reconstr Surg 2001;108:93-103. [4] Schneider AM, Morykwas MJ, Argenta LC. A new and reliable method of securing skin grafts to the difficult recipient bed. Plast Reconstr Surg 1998;102:1195-8. [5] Molnar JA, DeFranzo AJ, Argenta LC, et al. Acceleration of Integra incorporation in complex tissue defects with subatmospheric pressure. Plast Reconstr Surg 2004;113:1339-46. [6] McEwan W, Brown TLH, Muller MJ, et al. Suction dressings to secure a dermal substitute. Burns 2004;30:259-61. [7] Jeschke MG, Rose C, Bolder U, et al. Development of new reconstructive techniques: use of Integra in combination with fibrin glue and negative-pressure therapy for reconstruction of acute and chronic wounds. Plast Reconstr Surg 2004;113:525-30. [8] Argenta LC, Morykwas MJ. Vacuum-assisted closure. A new method for wound control and treatment: clinical experience. Ann Plast Surg 1997;38(6):563-77. [9] Blackburn II JH, Boemi L, Graham III WP, et al. Negative-pressure dressings as a bolster for skin grafts. Ann Plast Surg 1998;40(5):453-7. [10] Dantzer E, Braye FM. Reconstructive surgery using artificial dermis (Integra): results with 39 grafts. Br J Plast Surg 2001;54:659-64. [11] Heimbach D, Warden G, Dimick AR, et al. Multicenter postapproval clinical trial of IntegraÒ dermal regeneration template for burn treatment. J Burn Care Rehabil 2003;24/1:42-8. [12] Moiemen NS, Vlachou E, Frame JD, et al. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg 2006;117(7): 160-74.