- Email: [email protected]
Negative pressure wound therapy for initial management of giant omphalocele
The American Journal of Surgery (2016) -, -–-
Negative pressure wound therapy for initial management of giant omphalocele Beau Aldridge, M.D.a, Alan P. Ladd, M.D.b, Jacqueline Kepple, NPa, Teresa Wingle, PTa, Christopher Ring, B.S.a, Evan R. Kokoska, M.D.a,* a
Peyton Manning Children’s Hospital, Department of pediatric surgery, 2001 W 86th St., Indianapolis, IN 46260, USA; bDepartment of Surgery, School of Medicine, Indiana University, Riley Hospital for Children, Indianapolis, IN, USA KEYWORDS: Omphalocele; Wound VAC; Negative pressure wound therapy
Abstract BACKGROUND: Current treatment of giant omphalocele includes ‘‘paint and wait’’ or placement of mesh or silo. These methods are associated with high complication rates. We propose negative pressure wound therapy as an alternative. METHODS: Patients born between 2009 and 2014 with giant omphalocele were included. Outcomes analyzed were duration of therapy, time to full enteral feeds, treatment related complications, wound surface area over time, type, and time to definitive closure. RESULTS: Eight patients were reviewed. The median duration of therapy was 68 days. Median time to full enteral feeds was 19 days. There were no treatment discontinuations or complications including sac ruptures, wound infections, or fistulas. Wound contraction stopped at 2 months or around 7 cm2. All surviving patients underwent definitive closure. CONCLUSIONS: Negative pressure wound therapy is a safe and effective treatment for giant omphalocele that allows feeding, has a low complication rate, and is completed in 2 months. Ó 2016 Elsevier Inc. All rights reserved.
Omphalocele is a rare congenital anomaly that affects about 1 in 5,000 live births.1 Giant omphalocele, defined as an abdominal wall defect of 5 cm or greater, sac circumference of greater than 10 cm, or containing a majority of liver, is even more uncommon. Because of its rarity and complexity of management, there are currently no large studies determining the best method to treat giant omphalocele.2 Current methods consist of ‘‘paint and wait’’dusing antibacterial solutions to coat the overlying sac to foster eschar formation and epithelializationdor surgical management with or without silo or mesh. Both methods are associated with high complication rates.3 The authors declare no conflicts of interest. * Corresponding author. Tel.: 11-317-338-8857; fax: 11-317-338-8858. E-mail address: [email protected] Manuscript received July 13, 2015; revised manuscript November 25, 2015 0002-9610/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.11.009
Because of the difficulties associated with current treatment methods we have investigated negative pressure wound therapy (NPWT) as a possible alternative. Previous authors have used this method in the setting of giant omphalocele but only as salvage therapy after sac rupture or fistula formation occurred while attempting to treat with antibacterial paint or surgical intervention.4,5 To our knowledge, no reports exist detailing the use of NPWT for initial management of giant omphalocele.
Methods Study design This study represents a retrospective chart review of patients born between July 30, 2009 and July 30, 2014 at a
2
The American Journal of Surgery, Vol -, No -, - 2016
single tertiary referral center. The study was approved by St. Vincent Hospital, Indianapolis Institutional Review Board. Subjects were identified from the neonatal database ‘‘NeoData’’, version 6, (Isoprime Corporation Lisle, IL) using the search term ‘‘omphalocele.’’ A list of 22 patients was returned. In our institution patients with omphalocele greater than 10 cm in circumference or 5 cm in diameter that cannot be safely closed primarily based on clinical judgment are treated with NPWT within the first 5 days of life. Of the 22 patients, 8 patients met these criteria. The remaining 14 patients underwent primary closure because of small size of the defect and were therefore excluded from the study. Demographic data including gestational age, type of delivery, and comorbid conditions were collected. Outcomes analyzed were the duration of therapy in days, time to full enteral feeds (defined as all nutritional calories obtained enterally), complications associated with treatment, healing measured by decrease in surface area over time, type, and time to definitive repair.
may be applied to reduce buildup of fibrinous exudate. The umbilical cord may be trimmed as needed within the first 2 weeks. Over the duration of therapy, we have noted thinning of the omphalocele sac especially over solid organs such as the liver. In this case, we have added biologic dressing over the affected area and placed the negative pressure dressing on top. If the skin becomes irritated Stomahesive powder (Convatec, Bridgewater, NJ, USA) is initially applied. If this is not effective, Allevyn foam (Smith and Nephew, London, UK) is applied to the area and the adhesive film applied over the foam. If this does not relieve the irritation, the negative pressure dressing may be removed and wet to dry dressings applied. If the system loses suction, reinforcement may be required with adhesive film. There were no therapy discontinuations in our study for skin irritation or loss of suction. Measurements of omphalocele size were taken weekly or every other week. Length was defined as the longest dimension of the omphalocele and width the shortest. Healing was defined as a decrease in the surface area (L ! W) over time. Type and time to definitive repair were recorded.
Negative pressure wound therapy method For all patients, we used the NPWT device, InfoVAC (vacuum assisted closure), VersaFoam (white foam), and GranuFoam (black foam) from Kinetic Concepts Incorporated (KCI, San Antonio, TX). Therapy is initiated on the 1st or 2nd day of life, but no later than the 5th day. The omphalocele area is cleansed with normal saline. The periwound area is prepped with ‘‘No-sting’’ skin prep (Smith and Nephew, London, UK). Mepitel (Molnlycke Health Care, Gothenburg, Sweden) is then applied to the entire omphalocele. Depending on the size of the omphalocele, the Mepitel may be cut to conform to the spherical shape and 2 sheets of Mepitel may be used to cover large omphaloceles. White foam is cut in half to reduce the height and is applied over the Mepitel. Two pieces of white foam may be used to cover large defects and may be modified to help assume a more spherical shape. Black foam is also cut to about 1/4 to 1/2 inch in height and applied over the white foam (Fig. 1). Reducing the height of the black and white foam simplifies application and helps the dressing conform to the shape of the omphalocele. Next a 2 inch strip of clear adhesive film supplied with the system is applied in a 12 o’clock to 6 o’clock position and then from a 9 o’clock to 3 o’clock position. This helps stabilize the omphalocele to prevent occlusion of vascular structures that may otherwise kink if the omphalocele shifts. Four individual pieces of clear film are then cut to size to cover the remaining black foam while being careful to cover as little skin as possible. A quarter sized defect is made in the clear film at the apex of the omphalocele. The ‘‘daisy connector’’ is then applied. The negative pressure system is then set at 25 -mm Hg initially. If the mean arterial pressure is greater than 50 -mm Hg, the system is set to 50 -mm Hg. Dressings are changed twice weekly by our wound care team. During dressing changes, Santyl (Smith and Nephew, London, UK)
Results Demographics Eight total patients met inclusion criteria. All patients were delivered by Cesarean section with intact omphalocele sacs. One patient died of unrelated causes after 7 days of treatment. This patient has been included in the demographic analysis but was excluded from further outcomes analysis because of lack of data. There were 5 boys and 3 girls. Median gestational weight was 2,845 g (range 1070 g to 3630 g). Median gestational age was 37 weeks (range 29 to 39 weeks). Median number of comorbid conditions was 5 (range 0 to 18) and included cardiovascular, respiratory, urinary, genetic, hematopoietic, and gastrointestinal conditions.
Major outcomes There were no complications or deaths secondary to treatment. Specifically, there were no wound infections, no fistulas, and no sac ruptures. Median time to 1st enteral feed was 6 days (range 2 to 31 days). Median time to full enteral feeds was 19 days (range 10 to 44 days). Median length of hospital stay was 70 days (range 51 to 339 days).
Wound healing Median defect size was 66 cm2 (range 27 to 176 cm2) or about 8 ! 8 cm (range 6 ! 4.5 to 11 ! 16 cm). Median duration of NPWT was 68 days (range 30 to 186 days). In general, clinically significant wound healing stopped at 2 months or about 7 cm2 regardless of the size of the omphalocele (Fig. 2). All 7 surviving patients underwent definitive
B. Aldridge et al.
Negative pressure treatment of neonatal omphalocele
Figure 1
3
Illustrated method for application of negative pressure dressing to be printed for easy reference.
repair. Five primary and 2 mesh closures were performed. Average time to closure was 8 to 9 months and ranged from 5 to 6 months to 1 year.
Comments The 1st reported treatment of omphalocele was in 1899.6 At that time, the omphalocele sac was treated with an alcohol solution as an antibacterial agent and to thicken the omphalocele sac. The use of topical agents to thicken and epithelialize the sac are still in use today. In the mid 20th century, mesh and silos were introduced as adjuncts to treatment. Despite these advances, patients with giant omphalocele still
have unacceptably high complication rates. For example, in a 2011 series of 20 patients treated with a combination of topical agents followed by surgical therapy 3/20 (15%) experienced sac ruptures, 2/20 (10%) became septic from sac infections, and 1/20 (5%) developed jejunal perforation after silo placement3 in our series we had no sac ruptures, no infections, and no fistula formation. In a 2009 review of operative techniques for primary management of omphalocele 9/14 (64%) patients became septic after operative intervention which often included mesh or silo. With a prosthesis in place, it is not surprising to see rates of infection this high. Operative intervention also delays enteral feeding with an average of 33 days to full enteral feeds as opposed to 19 days in our study.7 We suspect this effect is due to ‘‘NPO days’’ for
4
Figure 2 Decrease in surface area over time with NPWT with associated patient data. (*) Patient died after 7 days of treatment of unrelated causes.
surgery and development of intra-abdominal complications such as ileus, abscess, and fistulas that preclude enteral feeding. Second, children treated with NPWT can be handled by caregivers making it easier to insert nasal feeding tubes or to feed orally. NPWT is gentle and able to be applied within the 1st few days of life to newborns as small as 1,070 g and as young as 29 weeks without sac rupture or other complications. To our knowledge, there are no reports of using NPWT on neonates of this age and size. The young, low birth weight patients with giant omphalocele generally have severe pulmonary hypoplasia requiring ventilation. There was no respiratory compromise seen in our patients with the application of therapy. The largest omphalocele treated was 11 ! 16 cmdessentially the entire abdominal wall of the newborn. Often, this type of omphalocele is difficult to treat with topical solutions because of the tendency of the abdominal contents to kink causing vascular compromise and sac rupture.3 With negative pressure dressings, the contents are stabilized and protected. Wound healing in our study occurred as quickly as 1 month but was complete at about 2 months for all children regardless of size of the omphalocele. This is in contrast to the application of silver sulfadiazine which averages 6 months.3 In our early experience, we left the negative pressure dressing in place for as long as 6 months; however, we noticed that clinically significant wound healing stopped around 2 months or 7 cm2. At this point most of the sac is epithelialized and a thick eschar develops over the small remaining portion. Another advantage of the negative pressure dressing is that it is changed twice per week as opposed to once per day for most of the other topical agents. Of note, our study was conducted at a tertiary referral center where all patients had prenatal diagnosis of giant omphalocele and were delivered by Cesarean section with intact omphalocele sacs. In addition, we have a dedicated wound care team accustomed to treating newborns with other complex wound problems including gastroschisis, necrotizing fasciitis and wound dehiscence after anorectal, and other procedures. All patients in our institution with giant omphalocele are treated with NPWT; therefore, we lack a true control group
The American Journal of Surgery, Vol -, No -, - 2016 for comparison. Instead, we have used historical controls. We did not address the outcomes of the remaining 14 patients who underwent primary closure because they are truly a different kind of patient. It is possible that some of these patients may have benefited from NPWT especially if primary closure caused respiratory compromise through increased intra-abdominal pressure. Future studies in other patient populations and settings would be helpful to verify and extend these results. In addition, studies comparing our results to contemporary cohorts treated with standard methods would be valuable. Negative pressure dressings for treatment of giant omphalocele mark a major improvement over topical solutions and surgical intervention. The foam protects the sac and the adhesive film provides stability. This prevents rupture, infection, and vascular compromise. The child can be easily held, transported, and fed. Dressings are changed only twice a week. No operative intervention is required reducing the amount of physiologic stress on the underdeveloped newborn and permitting early enteral feeding. Treatment can begin on the first day of life and is usually complete by 2 months regardless of omphalocele size. In our patient population, NPWT has proven to be a safe, convenient, and effective treatment for giant omphalocele.
References 1. Canfield MA, Honein MA, Yuskiv N, et al. National estimates and race/ ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin Mol Teratol 2006;76:747–56. 2. van Eijck FC, Aronson DA, Hoogeveen YL, et al. Past and current surgical treatment of giant omphalocele: outcome of a questionnaire sent to authors. J Pediatr Surg 2011;46:482–8. 3. Elin SH, Langer JC. Delayed management of giant omphalocele using silver sulfadiazine cream: an 18-year experience. J Pediatr Surg 2012; 47:494–500. 4. Binet A, Gelas T, Jochault-Ritz S, et al. VACÒ therapy a therapeutic alternative in giant omphalocele treatment: a multicenter study. J Plast Reconstr Aesthet Surg 2013;66:e373–5. 5. Kilbride KE1, Cooney DR, Custer MD. Vacuum-assisted closure: a new method for treating patients with giant omphalocele. J Pediatr Surg 2006;41:212–5. 6. Coran A, Adzick NS, Krummel T, et al. Pediatric Surgery. Chapter 75: Congenital Defects of the Abdominal Wall (973-984). Philadelphia: Saunders Elsevier Inc; 2012. 7. Mitanchez D1, Walter-Nicolet E, Humblot A, et al. Neonatal care in patients with giant ompholocele: arduous management but favorable outcomes. J Pediatr Surg 2010;45:1727–33.
Discussion DR. James Madura (Phoenix, Arizona): I have two questions. The first regards patient selection. You identified 22 patients who met your criteria, yet only eight were treated with this therapy. Were the others not giant omphaloceles? Did they have ruptured sacs at delivery, other complications or was this simply provider preference? Do you know how the other
B. Aldridge et al.
Negative pressure treatment of neonatal omphalocele
subjects fared? And do you think this may have skewed your results concerning comparison to historic controls? If the others were comparable at delivery, why not do a comparison to see if this negative pressure really was better than conventional therapy. Secondly, early, full enteral feeding is obviously important. What do you attribute the ability to achieve early or enteral feeding based on negative pressure therapy. DR. Aldridge: In regards to your first question, the eight patients that we selected, we were looking for giant omphalocele basically for the toughest patients to where this method would really be a major advantage. Looking at, overuse of wound vac, I think the patients with the smaller omphalocele were eliminated in that 22 and those were closed primarily. The other conditions that were caught in this database were things like gastroschisis or congential umbilical hernia that were coded as omphalocele and all those patients were closed primarily. Interestingly, we have looked at comparison studies looking over the past five same time period between St. Vincent, Peyton Manning Children’s Hospital and Reilly Children’s.
5
Your second question. I think the key with the negative pressure wound therapy, it doesn’t really, you know, put any stress on the bowel at all as an operative intervention would. That’s the first thing. The second thing is a child can be handled so if you need to put a feeding tube in, if the mother wants to hold the child and nurse or feed him with a bottle, they can. So those are probably the two main reasons I think. DR. William C. Cirocco (Columbus, Ohio): I’m just curious, what’s the next step in these infants? When do they get their abdominal wall reconstructed? DR. Aldridge: Ultimately, yes. That’s another advantage of using a general method like negative pressure wound therapy. It allows the child to mature. Most of these children have multiple comorbidities and depending on the age of the child, usually around two years old, they may have a staged operation, you know, first to bring the abdominal wall partly close to the midline, oftentimes using a bridging mesh if necessary, and then later on that may be closed even further several years after that.
Negative pressure wound therapy for initial management of giant omphalocele Beau Aldridge, M.D.a, Alan P. Ladd, M.D.b, Jacqueline Kepple, NPa, Teresa Wingle, PTa, Christopher Ring, B.S.a, Evan R. Kokoska, M.D.a,* a
Peyton Manning Children’s Hospital, Department of pediatric surgery, 2001 W 86th St., Indianapolis, IN 46260, USA; bDepartment of Surgery, School of Medicine, Indiana University, Riley Hospital for Children, Indianapolis, IN, USA KEYWORDS: Omphalocele; Wound VAC; Negative pressure wound therapy
Abstract BACKGROUND: Current treatment of giant omphalocele includes ‘‘paint and wait’’ or placement of mesh or silo. These methods are associated with high complication rates. We propose negative pressure wound therapy as an alternative. METHODS: Patients born between 2009 and 2014 with giant omphalocele were included. Outcomes analyzed were duration of therapy, time to full enteral feeds, treatment related complications, wound surface area over time, type, and time to definitive closure. RESULTS: Eight patients were reviewed. The median duration of therapy was 68 days. Median time to full enteral feeds was 19 days. There were no treatment discontinuations or complications including sac ruptures, wound infections, or fistulas. Wound contraction stopped at 2 months or around 7 cm2. All surviving patients underwent definitive closure. CONCLUSIONS: Negative pressure wound therapy is a safe and effective treatment for giant omphalocele that allows feeding, has a low complication rate, and is completed in 2 months. Ó 2016 Elsevier Inc. All rights reserved.
Omphalocele is a rare congenital anomaly that affects about 1 in 5,000 live births.1 Giant omphalocele, defined as an abdominal wall defect of 5 cm or greater, sac circumference of greater than 10 cm, or containing a majority of liver, is even more uncommon. Because of its rarity and complexity of management, there are currently no large studies determining the best method to treat giant omphalocele.2 Current methods consist of ‘‘paint and wait’’dusing antibacterial solutions to coat the overlying sac to foster eschar formation and epithelializationdor surgical management with or without silo or mesh. Both methods are associated with high complication rates.3 The authors declare no conflicts of interest. * Corresponding author. Tel.: 11-317-338-8857; fax: 11-317-338-8858. E-mail address: [email protected] Manuscript received July 13, 2015; revised manuscript November 25, 2015 0002-9610/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.11.009
Because of the difficulties associated with current treatment methods we have investigated negative pressure wound therapy (NPWT) as a possible alternative. Previous authors have used this method in the setting of giant omphalocele but only as salvage therapy after sac rupture or fistula formation occurred while attempting to treat with antibacterial paint or surgical intervention.4,5 To our knowledge, no reports exist detailing the use of NPWT for initial management of giant omphalocele.
Methods Study design This study represents a retrospective chart review of patients born between July 30, 2009 and July 30, 2014 at a
2
The American Journal of Surgery, Vol -, No -, - 2016
single tertiary referral center. The study was approved by St. Vincent Hospital, Indianapolis Institutional Review Board. Subjects were identified from the neonatal database ‘‘NeoData’’, version 6, (Isoprime Corporation Lisle, IL) using the search term ‘‘omphalocele.’’ A list of 22 patients was returned. In our institution patients with omphalocele greater than 10 cm in circumference or 5 cm in diameter that cannot be safely closed primarily based on clinical judgment are treated with NPWT within the first 5 days of life. Of the 22 patients, 8 patients met these criteria. The remaining 14 patients underwent primary closure because of small size of the defect and were therefore excluded from the study. Demographic data including gestational age, type of delivery, and comorbid conditions were collected. Outcomes analyzed were the duration of therapy in days, time to full enteral feeds (defined as all nutritional calories obtained enterally), complications associated with treatment, healing measured by decrease in surface area over time, type, and time to definitive repair.
may be applied to reduce buildup of fibrinous exudate. The umbilical cord may be trimmed as needed within the first 2 weeks. Over the duration of therapy, we have noted thinning of the omphalocele sac especially over solid organs such as the liver. In this case, we have added biologic dressing over the affected area and placed the negative pressure dressing on top. If the skin becomes irritated Stomahesive powder (Convatec, Bridgewater, NJ, USA) is initially applied. If this is not effective, Allevyn foam (Smith and Nephew, London, UK) is applied to the area and the adhesive film applied over the foam. If this does not relieve the irritation, the negative pressure dressing may be removed and wet to dry dressings applied. If the system loses suction, reinforcement may be required with adhesive film. There were no therapy discontinuations in our study for skin irritation or loss of suction. Measurements of omphalocele size were taken weekly or every other week. Length was defined as the longest dimension of the omphalocele and width the shortest. Healing was defined as a decrease in the surface area (L ! W) over time. Type and time to definitive repair were recorded.
Negative pressure wound therapy method For all patients, we used the NPWT device, InfoVAC (vacuum assisted closure), VersaFoam (white foam), and GranuFoam (black foam) from Kinetic Concepts Incorporated (KCI, San Antonio, TX). Therapy is initiated on the 1st or 2nd day of life, but no later than the 5th day. The omphalocele area is cleansed with normal saline. The periwound area is prepped with ‘‘No-sting’’ skin prep (Smith and Nephew, London, UK). Mepitel (Molnlycke Health Care, Gothenburg, Sweden) is then applied to the entire omphalocele. Depending on the size of the omphalocele, the Mepitel may be cut to conform to the spherical shape and 2 sheets of Mepitel may be used to cover large omphaloceles. White foam is cut in half to reduce the height and is applied over the Mepitel. Two pieces of white foam may be used to cover large defects and may be modified to help assume a more spherical shape. Black foam is also cut to about 1/4 to 1/2 inch in height and applied over the white foam (Fig. 1). Reducing the height of the black and white foam simplifies application and helps the dressing conform to the shape of the omphalocele. Next a 2 inch strip of clear adhesive film supplied with the system is applied in a 12 o’clock to 6 o’clock position and then from a 9 o’clock to 3 o’clock position. This helps stabilize the omphalocele to prevent occlusion of vascular structures that may otherwise kink if the omphalocele shifts. Four individual pieces of clear film are then cut to size to cover the remaining black foam while being careful to cover as little skin as possible. A quarter sized defect is made in the clear film at the apex of the omphalocele. The ‘‘daisy connector’’ is then applied. The negative pressure system is then set at 25 -mm Hg initially. If the mean arterial pressure is greater than 50 -mm Hg, the system is set to 50 -mm Hg. Dressings are changed twice weekly by our wound care team. During dressing changes, Santyl (Smith and Nephew, London, UK)
Results Demographics Eight total patients met inclusion criteria. All patients were delivered by Cesarean section with intact omphalocele sacs. One patient died of unrelated causes after 7 days of treatment. This patient has been included in the demographic analysis but was excluded from further outcomes analysis because of lack of data. There were 5 boys and 3 girls. Median gestational weight was 2,845 g (range 1070 g to 3630 g). Median gestational age was 37 weeks (range 29 to 39 weeks). Median number of comorbid conditions was 5 (range 0 to 18) and included cardiovascular, respiratory, urinary, genetic, hematopoietic, and gastrointestinal conditions.
Major outcomes There were no complications or deaths secondary to treatment. Specifically, there were no wound infections, no fistulas, and no sac ruptures. Median time to 1st enteral feed was 6 days (range 2 to 31 days). Median time to full enteral feeds was 19 days (range 10 to 44 days). Median length of hospital stay was 70 days (range 51 to 339 days).
Wound healing Median defect size was 66 cm2 (range 27 to 176 cm2) or about 8 ! 8 cm (range 6 ! 4.5 to 11 ! 16 cm). Median duration of NPWT was 68 days (range 30 to 186 days). In general, clinically significant wound healing stopped at 2 months or about 7 cm2 regardless of the size of the omphalocele (Fig. 2). All 7 surviving patients underwent definitive
B. Aldridge et al.
Negative pressure treatment of neonatal omphalocele
Figure 1
3
Illustrated method for application of negative pressure dressing to be printed for easy reference.
repair. Five primary and 2 mesh closures were performed. Average time to closure was 8 to 9 months and ranged from 5 to 6 months to 1 year.
Comments The 1st reported treatment of omphalocele was in 1899.6 At that time, the omphalocele sac was treated with an alcohol solution as an antibacterial agent and to thicken the omphalocele sac. The use of topical agents to thicken and epithelialize the sac are still in use today. In the mid 20th century, mesh and silos were introduced as adjuncts to treatment. Despite these advances, patients with giant omphalocele still
have unacceptably high complication rates. For example, in a 2011 series of 20 patients treated with a combination of topical agents followed by surgical therapy 3/20 (15%) experienced sac ruptures, 2/20 (10%) became septic from sac infections, and 1/20 (5%) developed jejunal perforation after silo placement3 in our series we had no sac ruptures, no infections, and no fistula formation. In a 2009 review of operative techniques for primary management of omphalocele 9/14 (64%) patients became septic after operative intervention which often included mesh or silo. With a prosthesis in place, it is not surprising to see rates of infection this high. Operative intervention also delays enteral feeding with an average of 33 days to full enteral feeds as opposed to 19 days in our study.7 We suspect this effect is due to ‘‘NPO days’’ for
4
Figure 2 Decrease in surface area over time with NPWT with associated patient data. (*) Patient died after 7 days of treatment of unrelated causes.
surgery and development of intra-abdominal complications such as ileus, abscess, and fistulas that preclude enteral feeding. Second, children treated with NPWT can be handled by caregivers making it easier to insert nasal feeding tubes or to feed orally. NPWT is gentle and able to be applied within the 1st few days of life to newborns as small as 1,070 g and as young as 29 weeks without sac rupture or other complications. To our knowledge, there are no reports of using NPWT on neonates of this age and size. The young, low birth weight patients with giant omphalocele generally have severe pulmonary hypoplasia requiring ventilation. There was no respiratory compromise seen in our patients with the application of therapy. The largest omphalocele treated was 11 ! 16 cmdessentially the entire abdominal wall of the newborn. Often, this type of omphalocele is difficult to treat with topical solutions because of the tendency of the abdominal contents to kink causing vascular compromise and sac rupture.3 With negative pressure dressings, the contents are stabilized and protected. Wound healing in our study occurred as quickly as 1 month but was complete at about 2 months for all children regardless of size of the omphalocele. This is in contrast to the application of silver sulfadiazine which averages 6 months.3 In our early experience, we left the negative pressure dressing in place for as long as 6 months; however, we noticed that clinically significant wound healing stopped around 2 months or 7 cm2. At this point most of the sac is epithelialized and a thick eschar develops over the small remaining portion. Another advantage of the negative pressure dressing is that it is changed twice per week as opposed to once per day for most of the other topical agents. Of note, our study was conducted at a tertiary referral center where all patients had prenatal diagnosis of giant omphalocele and were delivered by Cesarean section with intact omphalocele sacs. In addition, we have a dedicated wound care team accustomed to treating newborns with other complex wound problems including gastroschisis, necrotizing fasciitis and wound dehiscence after anorectal, and other procedures. All patients in our institution with giant omphalocele are treated with NPWT; therefore, we lack a true control group
The American Journal of Surgery, Vol -, No -, - 2016 for comparison. Instead, we have used historical controls. We did not address the outcomes of the remaining 14 patients who underwent primary closure because they are truly a different kind of patient. It is possible that some of these patients may have benefited from NPWT especially if primary closure caused respiratory compromise through increased intra-abdominal pressure. Future studies in other patient populations and settings would be helpful to verify and extend these results. In addition, studies comparing our results to contemporary cohorts treated with standard methods would be valuable. Negative pressure dressings for treatment of giant omphalocele mark a major improvement over topical solutions and surgical intervention. The foam protects the sac and the adhesive film provides stability. This prevents rupture, infection, and vascular compromise. The child can be easily held, transported, and fed. Dressings are changed only twice a week. No operative intervention is required reducing the amount of physiologic stress on the underdeveloped newborn and permitting early enteral feeding. Treatment can begin on the first day of life and is usually complete by 2 months regardless of omphalocele size. In our patient population, NPWT has proven to be a safe, convenient, and effective treatment for giant omphalocele.
References 1. Canfield MA, Honein MA, Yuskiv N, et al. National estimates and race/ ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin Mol Teratol 2006;76:747–56. 2. van Eijck FC, Aronson DA, Hoogeveen YL, et al. Past and current surgical treatment of giant omphalocele: outcome of a questionnaire sent to authors. J Pediatr Surg 2011;46:482–8. 3. Elin SH, Langer JC. Delayed management of giant omphalocele using silver sulfadiazine cream: an 18-year experience. J Pediatr Surg 2012; 47:494–500. 4. Binet A, Gelas T, Jochault-Ritz S, et al. VACÒ therapy a therapeutic alternative in giant omphalocele treatment: a multicenter study. J Plast Reconstr Aesthet Surg 2013;66:e373–5. 5. Kilbride KE1, Cooney DR, Custer MD. Vacuum-assisted closure: a new method for treating patients with giant omphalocele. J Pediatr Surg 2006;41:212–5. 6. Coran A, Adzick NS, Krummel T, et al. Pediatric Surgery. Chapter 75: Congenital Defects of the Abdominal Wall (973-984). Philadelphia: Saunders Elsevier Inc; 2012. 7. Mitanchez D1, Walter-Nicolet E, Humblot A, et al. Neonatal care in patients with giant ompholocele: arduous management but favorable outcomes. J Pediatr Surg 2010;45:1727–33.
Discussion DR. James Madura (Phoenix, Arizona): I have two questions. The first regards patient selection. You identified 22 patients who met your criteria, yet only eight were treated with this therapy. Were the others not giant omphaloceles? Did they have ruptured sacs at delivery, other complications or was this simply provider preference? Do you know how the other
B. Aldridge et al.
Negative pressure treatment of neonatal omphalocele
subjects fared? And do you think this may have skewed your results concerning comparison to historic controls? If the others were comparable at delivery, why not do a comparison to see if this negative pressure really was better than conventional therapy. Secondly, early, full enteral feeding is obviously important. What do you attribute the ability to achieve early or enteral feeding based on negative pressure therapy. DR. Aldridge: In regards to your first question, the eight patients that we selected, we were looking for giant omphalocele basically for the toughest patients to where this method would really be a major advantage. Looking at, overuse of wound vac, I think the patients with the smaller omphalocele were eliminated in that 22 and those were closed primarily. The other conditions that were caught in this database were things like gastroschisis or congential umbilical hernia that were coded as omphalocele and all those patients were closed primarily. Interestingly, we have looked at comparison studies looking over the past five same time period between St. Vincent, Peyton Manning Children’s Hospital and Reilly Children’s.
5
Your second question. I think the key with the negative pressure wound therapy, it doesn’t really, you know, put any stress on the bowel at all as an operative intervention would. That’s the first thing. The second thing is a child can be handled so if you need to put a feeding tube in, if the mother wants to hold the child and nurse or feed him with a bottle, they can. So those are probably the two main reasons I think. DR. William C. Cirocco (Columbus, Ohio): I’m just curious, what’s the next step in these infants? When do they get their abdominal wall reconstructed? DR. Aldridge: Ultimately, yes. That’s another advantage of using a general method like negative pressure wound therapy. It allows the child to mature. Most of these children have multiple comorbidities and depending on the age of the child, usually around two years old, they may have a staged operation, you know, first to bring the abdominal wall partly close to the midline, oftentimes using a bridging mesh if necessary, and then later on that may be closed even further several years after that.