Development of a novel method of progressive temporary abdominal closure

Development of a novel method of progressive temporary abdominal closure

Development of a novel method of progressive temporary abdominal closure Michael D. Goodman, MD, Timothy A. Pritts, MD, PhD, and Betty J. Tsuei, MD, C...

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Development of a novel method of progressive temporary abdominal closure Michael D. Goodman, MD, Timothy A. Pritts, MD, PhD, and Betty J. Tsuei, MD, Cincinnati, OH

Background. This paper describes our experience with a novel method of temporary abdominal closure that permits frequent reassessment of the abdominal contents and progressive reapproximation of the fascial edges without compromising definitive fascial closure outcomes. Methods. We developed a novel method of temporary abdominal closure, which we have named the frequent assessment temporary abdominal closure (FASTAC). The records of patients who underwent planned relaparotomy during 5 years were reviewed. The data collected included patient demographics, indication for operation, number of operations, duration of temporary abdominal closure placement, hospital duration of stay, method of definitive abdominal closure, and subsequent ventral hernia repair. Results. One hundred and thirty-three patients underwent 308 temporary abdominal closure placements, including 16 patients who had a FASTAC placed for open abdomen management. FASTAC remained in place for a significantly greater time with more frequent reassessment. Fascial closure techniques were not different in FASTAC patients. FASTAC patients had a significantly greater duration of stay, which suggests selective placement in a more complicated patient population. The materials for frequent assessment temporary abdominal closure cost only $38 compared with $350 for a large piece of Silastic. Conclusion. FASTAC is a novel, cost-effective method of temporary abdominal closure that allows for frequent bedside intra-abdominal surveillance, maintains abdominal domain, and does not compromise abdominal closure outcomes in the management of the open abdomen. (Surgery 2010;148:799-806.) From the Department of Surgery, Division of Trauma and Critical Care, University of Cincinnati, Cincinnati, OH

EFFECTIVE ISCHEMIA,

CONTROL OF INTRA-ABDOMINAL HEMORRHAGE, INFECTION,

AND

HYPERTENSION

BY

DAMAGE

CONTROL LAPAROTOMY, SECOND-LOOK LAPAROTOMY, OR

has motivated the increasingly common use of temporary abdominal closure (TAC) techniques for the management of critically ill patients. These techniques allow the surgeon to resolve physiologic insults and complete resuscitation prior to undertaking definitive fascial closure.1,2 Although advances in modern critical care have increased the survival of severely ill or injured patients, there is little consensus on the optimal method and timing of staged abdominal closure and fascial reapproximation.

DECOMPRESSIVE LAPAROTOMY

Presented at the Central Surgical Association 2010 Annual Meeting, March 10–13, 2010, Chicago, Illinois. Accepted for publication July 13, 2010. Reprint requests: Michael D. Goodman, MD, Department of Surgery, University of Cincinnati, Mail Location 0558, 231 Albert Sabin Way, Cincinnati, OH 45267. E-mail: [email protected]. 0039-6060/$ - see front matter Ó 2010 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2010.07.035

Maintaining or reclaiming the intra-abdominal domain and establishing definitive fascial closure can be a formidable surgical challenge, which often requires serial and progressive fascial approximation.3 The ideal TAC method should contain the intra-abdominal viscera, protect the bowel from adhesion formation or external mechanical injury, prevent visceral desiccation, provide a homeostatic environment to decrease visceral edema, permit visual inspection of the abdomen, prevent contamination of the peritoneal cavity, control egress of peritoneal fluid, be applied rapidly, lend itself to multiple adjustments and applications, and be relatively inexpensive.4-6 Various strategies have been put forth to achieve these goals, including skin-only towel clip closure, the use of a large inert fluid (Bogota´) bag, absorbable or nonabsorbable mesh implantation, closed suction drains, or sophisticated commercially available closure systems.3,7 To date, no single technique has proven to be appropriate for all circumstances, and each strategy is associated with major shortcomings, including bowel fistula formation, retraction of the SURGERY 799

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abdominal fascia, and intestinal adherence to the prosthesis.8-10 We describe our initial experience with a novel TAC method that permits frequent reassessment of the abdominal contents and progressive controlled reapproximation of the fascial edges without compromising definitive fascial closure outcomes. MATERIALS AND METHODS A retrospective review of all patients who underwent planned relaparotomy at a level I trauma center and tertiary referral hospital between January 1, 2003, and December 31, 2008 was conducted. The patients were identified using hospital ICD-9 procedural code 54.12 indicating reopening of a recent laparotomy site and included in the study if they underwent TAC placement during an initial or subsequent operation. The study was approved by the University of Cincinnati Institutional Review Board. Medical records including patient demographics and operative reports during the inpatient stay were reviewed. The indication for operation, number of operations, method of TAC, duration of TAC placement, hospital duration of stay, and subsequent method of definitive abdominal closure were recorded. TAC groups were analyzed to determine the time to definitive closure, frequency of peritoneal reassessment, and method of definitive fascial closure. Perioperative outcomes including subsequent ventral hernia repair, complications after closure, and mortality were also noted. Student t test and Fisher exact test analyses were used as indicated to assess for statistical significance at a P value < .05. Data are as expressed mean ± standard error. Our novel method of TAC, a frequent assessment temporary abdominal closure (FASTAC), has been used at University Hospital since 2003. The material used for the FASTAC is transparent, thereby allowing periodic visual reassessment of the peritoneal cavity with progressive fascial edge reapproximation while minimizing adhesions between the abdominal viscera and the surrounding parietal peritoneum. Application of the FASTAC is at the judgment and experience of the attending surgeon. The FASTAC patch was fashioned from a clear plastic surgical drape commonly used in a slush or heat basin (OR Solutions Inc., Chantilly, VA). The drape was folded to a 4-fold thickness and trimmed to fit the length of the individual midline abdominal incision. A separate drape was prepared for each side of the abdominal cavity, measuring at least twice the width of the abdominal wall to leave

Fig 1. Diagram demonstrating placement of the FASTAC containing the intra-abdominal viscera along the peritoneal edges with an overlying modified vacuum closure. Arrows indicate the intra-abdominal portion of the FASTAC lining the parietal peritoneum.

excess drape in the midline to adjust for a tensionfree closure. The free tail edges of the drape were placed under the anterior abdominal wall superficial to the viscera and extend laterally to the paracolic gutters (Fig 1 and Fig 2, A). The midpoint of each side of the drape was then sutured with a running #1 polypropylene suture to the fascial edge along the entire length of the incision. Opposing fascial edges were brought toward each other with appropriate tension on the drape. The folded edges of the drape were then sutured together in the midline, taking care not to increase peak airway pressures during closure (Fig 2, B). A sterile, closed vacuum dressing to continuous wall suction was then fashioned using kerlix gauze to cover the drape with closed suction drains laid between the gauze and an overlying layer of blue towels. An Ioban dressing (3M, St Paul, MN) was placed over the entire wound to create a watertight seal. The vacuum dressing was removed to reassess the intra-abdominal viscera by visualization through the transparent drape every 48--72 h. The FASTAC was progressively tightened at that time by rolling the midline of the drape and resecuring it with additional running sutures as the intra-abdominal pressures permitted. This allowed a gradual fascial approximation and avoided the loss of abdominal domain (Fig 2, C). The drape can also be opened in the midline by cutting the suture holding each leaf together to access the peritoneal cavity and its contents prior to reapproximating the drape

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Fig 2. Insertion of FASTAC. (A) Securing the plastic drape to the fascia and tucking the lateral edges to the paracolic gutters. (B) Appearance of the appliance after initial insertion with plastic drape sutured to the fascia bilaterally and closed in the midline. (C) Sequential fascial reapproximation achieved by serial folding and suturing of the drape in the midline. (D) FASTAC appliance prior to removal and definitive fascial closure.

and fascial edges. Dressing changes were performed routinely at the bedside. Once adequate fascial apposition was achieved, the appliance was removed for definitive fascial closure in the operating room (Fig 2, D). RESULTS During the study period, 133 patients were managed with temporary abdominal closures. These patients underwent a total of 281 TAC procedures to replace their temporary closure devices during the course of their initial hospitalization. FASTAC adjustment accounted for 26 additional TAC-related procedures without necessitating appliance replacement. TACs were placed in patients on a variety of surgical services, including trauma, general surgery, transplant, and vascular surgery. Damage control laparotomy for trauma and release of the abdominal compartment syndrome were the most common primary indications for using TAC (Table I). The primary indication for use of a subsequent TAC device was for planned re-exploration and abdominal washout throughout the course of managing an open abdomen. Of the TAC procedures performed for continued intra-abdominal reassessment, the most common technique used was Silastic sheeting

(Dow Corning Corporation, Midland, MI) secured at the skin level only (Table II). Commercial vacuum-assisted closure (VAC) and FASTAC applications were performed more commonly as subsequent TAC methods for the prolonged management of the difficult open abdomen. Subsequent TAC techniques were applied for a greater duration than initial TAC placement (6.4 ± 0.7 days vs 2.8 ± 0.3 days; P < .001). For data analysis, the patients were placed into groups that had a FASTAC placed as part of the treatment of their open abdomen (FASTAC, 16 patients) and those who did not (non-FASTAC, 117 patients). The mean age of all patients who underwent TAC placement was 45 ± 2 years, with no difference between FASTAC and non-FASTAC groups. Similarly, there was no difference in gender distribution between groups (FASTAC 88% male patients, non-FASTAC 74% male patients; P = .36) with male patients comprising 76% of all TACs and female patients comprising 24% of all TACs. An analysis of TAC groups demonstrated that FASTACs remained in place for a significantly greater duration of time than other TAC methods. In addition, FASTAC placement allowed for more frequent surveillance of the abdominal viscera (Table III). Patients in whom FASTACs were

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Table I. Indications for TAC placement Indication

Table II. TAC techniques

Number (%)

Trauma Penetrating wounds Blunt injuries---MVC, MCC, assault General surgery Gastrointestinal perforation, leak Mesenteric ischemia Necrotizing pancreatitis Small bowel obstruction Subspecialty operative procedure Organ transplant---liver and pancreas Ruptured abdominal aortic aneurysm Surgical complications Abdominal compartment syndrome Postoperative intra-abdominal bleed Intra-abdominal sepsis Fascial dehiscence, infection Other resections/re-explorations

42 23 19 29 13 7 5 4 22 18

(32) (17) (14) (22) (10) (5) (4) (3) (17) (14)

4 (3) 36 16 12 4 4 4

(27) (12) (9) (3) (3) (3)

MCC, Motorcycle collision; MVC, motor vehicle collision.

placed, however, demonstrated a significantly greater duration of stay during initial admission. The mortality rates for FASTAC and non-FASTAC patients were not significantly different (Table III). Patients who required open abdomen management techniques in this study often had placement of multiple different closure devices during the course of their treatment. Of the 16 FASTAC patients, only 2 patients had the FASTAC as the only TAC, and 9 patients had the FASTAC as their final TAC technique prior to definitive fascial closure. Despite the increased hospital duration of stay and varied methods of TAC, FASTAC placement did not compromise the rates of delayed primary fascial closure or closure using mesh or dermal substitute reinforcement (Table IV). Of the patients who survived to discharge, those in whom a FASTAC was used at any time had a greater subsequent ventral hernia repair rate than nonFASTAC patients (5 of 12 patients [42%] vs 14 of 99 patients [14%]; P = .03). A subsequent analysis, however, demonstrated no difference in the delayed ventral hernia rate between non-FASTAC patients and those patients in whom the FASTAC was the final TAC method prior to definitive abdominal closure (2 of 6 patients [33%] vs 14 of 99 patients [14%]; P = .23). Additionally, 19% of FASTAC patients (n = 3) developed an enterocutaneous fistula, whereas 5% of nonFASTAC patients were noted to have a fistula (P = .36). Of the 3 patients in the FASTAC group who developed an enteric fistula, all were treated

Silastic (all) To skin To fascia Intraperitoneal drape and vacuum closure Commercial VAC device Skin closure only Wet to dry packing FASTAC Other/unknown ABRA

Initial placement

Subsequent placement

78 61 17 24

65 40 25 27

10 12 2 2 4 0

34 2 2 14 1 3

with multimodal TACs including directly applied vacuum dressings. Compared with the most common form of TAC at our institution, FASTAC materials incurred a lesser hospital charge. The transparent drape employed in the FASTAC cost only $38 versus $350 for the Silastic sheet used for TAC placement. DISCUSSION In the current study, we examined the use of a novel technique of TAC for the management of the open abdomen. We reviewed our TAC experience over a 5-year period and examined TAC methods to assist in delayed fascial closure. Our data show that application of the FASTAC did not compromise the outcomes of definitive abdominal closure in this complex cohort of critically ill patients. Selection of TAC technique is determined by the judgment, experience, training, and institutional practice patterns of surgeons who practice trauma and acute care surgery. Each technique has a distinct set of advantages and weaknesses.7,11 In addition, no single TAC method has proven to be appropriate for all circumstances. Skin approximation, as with towel clips, is rapid, inexpensive, and maintains abdominal domain but risks skin necrosis, recurrent abdominal compartment syndrome, or evisceration. The Bogota´ bag technique and silicone sheeting secured to the fascia allow for the quick insertion of a biologically inert material but do not protect from adhesion formation between the viscera and anterior abdominal wall.12 Absorbable mesh products are often used to prevent evisceration when there is a high risk of infection, but these techniques are associated with greater rates of ventral hernia and fascial retraction as the material incorporates. Commercially available VAC products prevent the loss of abdominal domain

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Table III. TAC outcomes

Duration of stay (days) Deaths TAC duration (days) Number of TAC reassessments

Table IV. Type of abdominal closure

FASTAC

NonFASTAC

P value

57 ± 8 4 (25%) 13 ± 2 4.1 ± 0.9

28 ± 2 18 (14%) 7±1 1.4 ± 0.2

<.001 .3 .04 <.001

and extend the amount of time of TAC use but have lesser volume reserve capacities and are not readily adjustable without replacement.13 Modified removable prostheses, such as the Wittmann patch,11 similarly allow for increased duration of the open abdomen with easy adjustment of medial fascial traction, but these options are costly and opaque, thereby preventing facile reassessment of the peritoneal cavity. Examination of the literature as well as a critical review of TAC methods used in our own institution demonstrates a lack of consensus regarding the optimal TAC method. The FASTAC technique provides several potential advantages over other methods. The appliance is transparent, permitting the evaluation of underlying peritoneal viscera to recognize bleeding, enteric contamination, infection, or fistula formation.6 The attachment of the FASTAC patch to the fascial edges allows for progressive fascial reapproximation with the option of closure reversal should intra-abdominal hypertension recur. Evenly distributed medial fascial traction prevents the loss of abdominal domain and avoidance of repeated suture damage to prevent compromising tissue viability.3 Finally, placing the drape beneath the parietal peritoneum helps not only to contain the abdominal viscera but also to prevent adherence of the bowel to the anterior abdominal wall, thereby decreasing the chance of bowel injury at the time of reexploration or definitive abdominal closure.14 An additional advantage of the FASTAC patch is a decreased cost compared with several other commonly placed TACs. Previous studies have delineated the financial burden of various methods of temporarily closing the abdomen and accounted for the frequent dressing changes and equipment and operating room time and personnel required. Our institutional practice to date has not included a protocol to dictate the method and timing of TAC placement and reassessment, leading to the use of multiple techniques even for a single patient. Our experience has ranged from simple Silastic closure of the skin or fascia to commercially available systems such as the ABRA

Primary Split thickness skin graft Mesh placement Dermal substitute Granulating

FASTAC

Non-FASTAC

P value

5 (31%) 3 (19%)

65 (55%) 9 (7%)

.11 .13

3 (19%) 0 (0%) 1 (6%)

22 (17%) 5 (4%) 3 (2%)

1.0 1.0 .41

and VAC products.15 Although the removable prostheses have been demonstrated to play an integral role in delayed fascial closure for many surgeons, these devices also bear a substantial cost. For instance, a single Wittmann patch has been priced in the literature at $1,400 to $4,900, and VAC supplies are estimated at $1,300 for 14 days of therapy, compared with the $38 expense of the warmer drape used in the FASTAC.11,16,17 Furthermore, periodic FASTAC reassessments, peritoneal visualization, and progressive fascial reapproximation can occur frequently at the bedside in the intensive care unit, eliminating the need for operating room time and its associated expenses. The use of inexpensive materials, however, does not seem to compromise clinical outcomes in patients who had the FASTAC placed. Overall, delayed fascial closure rates have varied widely in the literature, from 35% to 82% with the Wittmann patch and 31% to 100% with modified vacuum assisted techniques.5,11,14,16,18,19 Our study demonstrates an overall fascial closure rate of 86% in all TAC patients and 66% in all FASTAC patients who survived to discharge. Although FASTAC patients seem to have a greater subsequent ventral hernia repair rate, this study did not identify those patients who might have developed ventral hernias without repair to date or have had repairs at other institutions. Although the percentage of FASTAC patients who developed an enterocutaneous fistulae was greater than in the non-FASTAC group, this finding was not statistically significant. Heterogeneity among a small subgroup of patients who developed a fistula prevents a more comprehensive analysis of potential contributing factors, such as initial diagnosis requiring laparotomy, patient age, duration of clinical course, duration of TAC placement, and presence of bowel anastomosis. In addition, the use of multiple TAC techniques in individual patients makes it difficult to ascertain what role FASTAC played in either the development or prevention of these complications. Despite the use of a variety of TAC techniques in our institution during the study period, our data reveal several important aspects of the FASTAC

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experience. The results in Table III demonstrate that patients selected for TAC placement had a significantly greater hospital duration of stay, which suggests selective FASTAC placement in more challenging open abdominal cases. Notably, the FASTAC allowed for a significantly greater duration of device placement, during which frequent peritoneal reassessments every 48--72 h were possible. Although previous studies have shown that patients most likely to undergo primary fascial closure are those who can be closed during the first week after initial laparotomy because of lateral rectus retraction, use of the FASTAC for periods lasting nearly 2 weeks has provided equivalent primary closure rates.5 This study has several inherent limitations. Our study is a retrospective review of a modest number of patients, many of whom were treated using a variety of TAC techniques in addition to the FASTAC. In addition, the data gathered are limited by the accuracy and availability of the medical records themselves. A more robust prospective study with a specific institutional protocol regarding TAC selection and management would be needed to characterize the outcomes of FASTAC placement, especially in comparison with other commonly employed methods. FASTAC placement might not be the optimal open abdomen solution for all patients. For example, patients who require only 1 reoperation (ie, a second look for ischemia) and have a high likelihood of rapid definitive closure might not benefit from the use of the FASTAC. By contrast, patients who cannot undergo definitive fascial closure at a second laparotomy, however, could potentially benefit from FASTAC placement to prevent progressive lateral rectus retraction and improve the likelihood of delayed primary fascial closure. In conclusion, we introduce the FASTAC as a novel, inexpensive method of managing the complex open abdomen. This technique allows for frequent bedside intra-abdominal surveillance and maintains abdominal domain by promoting progressive fascial reapproximation. Selective use of the FASTAC in those patients who are anticipated to have a prolonged clinical course and require multiple intra-abdominal evaluations might result in improved abdominal closure outcomes.

REFERENCES 1. Burch JM, Ortiz VB, Richardson RJ, Martin RR, Mattox KL, Jordan GL Jr. Abbreviated laparotomy and planned reoperation for critically injured patients. Ann Surg 1992;215:47683; discussion 483-74.

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2. Rotondo MF, Schwab CW, McGonigal MD, Phillips GR III, Fruchterman TM, Kauder DR, et al. ‘‘Damage control’’: an approach for improved survival in exsanguinating penetrating abdominal injury. J Trauma 1993;35:375-82; discussion 382-3. 3. Vertrees A, Greer L, Pickett C, Nelson J, Wakefield M, Stojadinovic A, et al. Modern management of complex open abdominal wounds of war: a 5-year experience. J Am Coll Surg 2008;207:801-9. 4. Aydin C, Aytekin FO, Yenisey C, Kabay B, Erdem E, Kocbil G, et al. The effect of different temporary abdominal closure techniques on fascial wound healing and postoperative adhesions in experimental secondary peritonitis. Langenbecks Arch Surg 2008;393:67-73. 5. Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, et al. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg 2007;204:784-92. 6. Howdieshell TR, Proctor CD, Sternberg E, Cue´ JI, Mondy JS, Hawkins ML. Temporary abdominal closure followed by definitive abdominal wall reconstruction of the open abdomen. Am J Surg 2004;188:301-6. 7. Rutherford EJ, Skeete DA, Brasel KJ. Management of the patient with an open abdomen: techniques in temporary and definitive closure. Curr Probl Surg 2004;41:815-76. 8. Miller RS, Morris JA Jr, Diaz JJ Jr, Herring MB, May AK. Complications after 344 damage-control open celiotomies. J Trauma 2005;59:1365-71; discussion 1371-4. 9. Perez D, Wildi S, Demartines N, Bramkamp M, Koehler C, Clavien PA. Prospective evaluation of vacuum-assisted closure in abdominal compartment syndrome and severe abdominal sepsis. J Am Coll Surg 2007;205:586-92. 10. Teixeira PG, Salim A, Inaba K, Brown C, Browder T, Margulies D, et al. A prospective look at the current state of open abdomens. Am Surg 2008;74:891-7. 11. Tieu BH, Cho SD, Luem N, Riha G, Mayberry J, Schreiber MA. The use of the Wittmann Patch facilitates a high rate of fascial closure in severely injured trauma patients and critically ill emergency surgery patients. J Trauma 2008;65:865-70. 12. Aydin C, Aytekin FO, Tekin K, Kabay B, Yenisey C, Kocbil G, et al. Effect of temporary abdominal closure on colonic anastomosis and postoperative adhesions in experimental secondary peritonitis. World J Surg 2006;30:612-9. 13. Benninger E, Laschke MW, Cardell M, Keel M, Seifert B, Trentz O, et al. Intra-abdominal pressure development after different temporary abdominal closure techniques in a porcine model. J Trauma 2009;66:1118-24. 14. Barker DE, Kaufman HJ, Smith LA, Ciraulo DL, Richart CL, Burns RP. Vacuum pack technique of temporary abdominal closure: a 7-year experience with 112 patients. J Trauma 2000;48:201-6. 15. Jafri MA, Tevar AD, Lucia M, Thambi-Pillai T, Karachristos A, Trumbull L, et al. Temporary silastic mesh closure for adult liver transplantation: a safe alternative for the difficult abdomen. Liver Transpl 2007;13:258-65. 16. Bee TK, Croce MA, Magnotti LJ, Zarzaur BL, Maish GO III, Minard G, et al. Temporary abdominal closure techniques: a prospective randomized trial comparing polyglactin 910 mesh and vacuum-assisted closure. J Trauma 2008;65: 337-42. 17. Koss W, Ho HC, Yu M, Edwards K, Ghows M, Tan A, et al. Preventing loss of domain: a management strategy for closure of the ‘‘open abdomen’’ during the initial hospitalization. J Surg Educ 2009;66:89-95.

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18. Cothren CC, Moore EE, Johnson JL, Moore JB, Burch JM. One hundred percent fascial approximation with sequential abdominal closure of the open abdomen. Am J Surg 2006;192:238-42. 19. Hadeed JG, Staman GW, Sariol HS, Kumar S, Ross SE. Delayed primary closure in damage control laparotomy: the value of the Wittmann patch. Ann Surg 2007;73:10-2.

DISCUSSION Dr Fred Luchette (Maywood, IL): As I watched your slides, it occurred to me, when I deal with an open abdomen, I always try to save the fascia until I can get to a delayed primary closure. I noticed you’re using that to secure the bags to on the way in. Have you thought about adjusting it to the skin rather than the fascia? And then I want you to comment, does using a fascia for the securing of the drapes actually contribute to the ventral hernia rate that you’re seeing down the road with the primary closure using the FASTAC? But I have the sense from your data, it looked like you started with a Silastic sheet or some type of preliminary temporary abdominal closure, and then there was a selection decision made. We’re going to get these closed quickly within the first week, or they are going to be a prolonged, delayed closure, and then we’ll go to the FASTAC. So how do you see incorporating this into a prospective algorithm for study? The last comment is, those of us that have been dealing with these open avenues, the dreaded complication is the fistula. That open-air fistula is a nightmare. And I just heard some data from Wake Forest, in the last 10 years, using a different type of temporary abdominal closure with some of those commercial devices, they’ve had no fistulas in 10 years. I think that’s the gold standard where we really want to try to get to with these types of delayed temporary closures. Dr Michael D. Goodman (Cincinnati, OH): I do have to give credit for the development of the FASTAC to Dr Tsuei. She developed it at a previous institution and brought it back with her when she returned to the University of Cincinnati. In terms of where we attach the device, I think that the value of this technique actually comes in attaching it to the fascia to provide that continuous medial traction. Attaching it to the skin would over time allow the fascial retraction laterally and decrease the advantage of placing this device. And, certainly, placing it to the fascia, there is a certain risk of using that fascia initially, and it’s definitely a learning curve for how and when the adjustments need to be made to provide increased medial attraction. In terms of the prospective algorithm, currently, most patients undergoing initial temporary abdominal closure procedure, the Silastic is commonly used and especially by our transplant colleagues. Currently, our trauma and general surgery colleagues place an intraperitoneal drape. The same drape can just be placed intraperitoneally with holes cut in it to allow egress of peritoneal fluid, and then a modified VAC system, as I showed, placed on top. At second look laparotomy, 48--72 hours later, the decision can then be made and the algorithm can be

Goodman, Pritts, and Tsuei 805

initiated if this patient can have closure definitively within a day or 2 Certainly, placing a definitive closure device at that time, or just simply leaving that intraperitoneal drape, would be okay for the next 48--72 hours. Patients who are too critical and still need physiologic assessment and correction and will have a more prolonged open abdomen I think are the ones who are most appropriate to have the FASTAC placed. As for the enterocutaneous fistula rate, all the fistulas were actually identified after abdominal closure in these patients. As I said, they all did receive multi-modality therapy. So it’s hard to isolate the FASTAC itself. Certainly, if a fistula does form, probably the most appropriate thing to do is remove the device, allow the abdomen to granulate laterally, and then provide a skin graft to temporize the patient. Dr Marie Crandall (Chicago, IL): I have 2 questions. One is, you acknowledge that the length of stay for the subset of FASTAC patients is longer than traditional TAC patients. In addition, though it was not statistically significant, the fistula percentage and the mortality percentage were higher in the FASTAC patients. This may be due to selection bias, and it may also be due to some property of the FASTAC itself; for example, increased fistulization of at-risk bowel, development of recurrent abdominal compartment syndrome, or from erosion into blood vessels. It seems as though your data suggest that fistula rates were not increased, but you only looked at patients surviving to discharge. How do you intend to study or compare these? Then, the second question is, some authors have alleged that sewing material to the fascia, while helping achieve constant tension on the facial edges to prevent loss of intra-abdominal domain, can also lead to fascial necrosis and subsequent wound breakdown. You actually have the advantage of having a fairly large retrospective data set including the non-FASTAC devices sewn to the skin or sewn to the fascia. It might be interesting to compare your FASTAC with vacuum-assisted closure devices or nonfascial sutured closure devices, and have you looked at that? Dr Michael D. Goodman (Cincinnati, OH): Certainly, when we look back at the length of stay as well as the mortality, I think you hit exactly on the problem. It’s a problem of selection bias. The patients who were deemed to have a more prolonged, open abdominal management certainly were selected to have the FASTAC placed. So these patients had a longer length of stay. I don’t know that we could directly attribute the length of stay to the FASTAC placement rather than say it’s in association at this point. I think that’s a question best answered by a prospective algorithm, as we mentioned, at second-look laparotomy making that decision. In terms of the second question, the device comparison, certainly involvement of the fascia and suturing to the fascia is a risk, and it’s a great point that we could look back at other devices that we have inserted that are sewn to the fascia. I think that the difficulty in doing that is, at least in our institutional experience, the other devices that are sewn to the fascia, the Silastic and other devices,

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are actually not in for as long as the FASTAC is in. And I think that’s the significant advantage of using this is that we’ve been able to show prolonged duration of the device in the abdomen. Certainly, other devices such as

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the Wittmann patch involve the fascia as well, and I think that the advantage of this device over those devices is the opacity as well as the continued prevention of providing a barrier between the parietal and visceral peritoneum.