A New Nonoperative Treatment of Large Omphaloceles With a Polymer Membrane By Sigmund H. Ein and Barry Shandling 9 The management of a huge omphalocele that cannot be primarily closed presents many difficulties. When surgery is technically impossible, the application of a Silon pouch carries a serious risk of infection and painting the sac with tinctures has its own peculiar problems. A newborn baby with a large unruptured omphalocele was successfully treated by covering the sac with a skin-like polymer membrane that is flexible, elastic, and impervious to bacteria and water. The covering did not adhere to the underlying tissues and did not interfere with gastrointestinal function. Infection was not a problem. This material was wrapped around the trunk and covered with a dry sterile dressing. The entire dressing was removed after 3 wk, revealing a small residual area of granulations that subsequently healed at home. This baby was not operated upon. W e have also used this technique in a second newborn in w h o m the sac had ruptured. The rent was repaired and the membrane applied. This method does not eliminate later closure of the large ventral hernia, but certainly eliminates the necessity for surgery in the newborn period. I N D E X W O R D : Omphalocele.
CASE REPORTS Case 1 In September 1976, C.E., a 3300-g boy, was born with a large unruptured omphalocele in which liver, spleen, and most of the intestinal tract could be seen through the intact amniotic covering. Intravenous and nasogastric therapy were started, and in the newborn nursery, after the cord was tied and the clamp removed, the omphalocele sac was covered with a polymer membrane, marketed under the name Op-Site.* Gastrointestinal function started on the fifth day. On the seventh day, the baby developed signs and symptoms of sepsis, for which i.v. antibiotics (ampicillin and gentamicin) were given with good results. Fourteen days after the Op-Site covering was applied, one could see the amniotic sac liquefying beneath the transparent membrane and an offensive odor was noted. The abdomen (including the omphalocele) was wrapped with a dry sterile gauze dressing over the polymer membrane. This gauze dressing and the underlying Op-Site were removed 24 days after birth. The amniotic membrane had been replaced by granulation tissue, (covered with a thin purulent exudate) and skin had grown around the omphalocele three-quarters of the way to the granulations. The granulations were cleaned with a local antiseptic (Hygeol) solution, and epithelial coverage was complete within 4 wk. The baby had been discharged 2 wk before the residual ventral hernia was completely covered by skin. The ventral hernia was easily closed in one stage when the baby was 13 mo old.
*Smith and Nephew, Ltd., Lachine, Quebec, Canada. Journal of Pediatric Surgery, Vol. 13, No. 3 (June), 1978
Case 2 In January 1977, N.M., weighing 2200 g was born with a large ruptured omphalocele. The liver, spleen, and most of the gastrointestinal tract were all outside the omphalocele. The baby was immediately operated upon under general anesthesia, the abdominal contents were replaced into the amniotic sac, and the sac was closed with silk sutures. The repaired sac was covered with an antibiotic-impregnated gauze dressing, and several hours later, in the newborn nursery, this gauze dressing was removed and the repaired omphalocele sac was covered with Op-Site. The early postoperative period was very stormy, with episodes of seizure, sepsis, hypocalcemia, hypoglycemia, and cardiac failure. She was given the appropriate treatment, which included assisted ventilatory care, digita/ization, and antibiotics. During this difficult period her neurologic status was questionable but a CT scan showed only cerebral edema. She also had a prolonged gastrointestinal ileus that required nasogastric decompression and peripheral i.v. alimentation. The entire clinical picture slowly improved over a period of weeks. In the meantime, the Op-Site polymer membrane dressing was first changed on the 17th day, and several times thereafter over the next month, each time being covered with dry sterile gauze. By the 6th wk, Op-Site coverage of the omphalocele sac was no longer necessary as granulations had replaced the entire amniotic membrane. These granulations were treated with Hygeol dressings for a few weeks and the baby was discharged home with a large granulation-covered ventral hernia that eventually healed over with skin. This hernia will be repaired when she is between 1 and 2 yr of age.
DISCUSSION
Primary closure of a huge omphalocele is technically impossible, and many methods of immediate coverage of the large intact amniotic membrane sac have been employed. 1 TM All methods (operative and nonoperative) have had their problems, and some have been very difficult to solve. Painting unruptured omphalocele sacs with a tincture or aqueous solution has resulted in many problems: premature rupture of the eschar, sepsis from the frequently found puFrom the Division of General Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada. Presented before the 26th Annual Meeting of the American Academy of Pediatrics, Surgical Section, New York, New York, November6 8, 1977. Address reprint requests to Dr. Sigmund H. Ein, Division of General Surgery, The Hospital'for Sick Children. 9 1978 by Grune & Stratton, Inc. 0022 3468/78/1303-0009501.00/0 255
256
rulent collection beneath the eschar, incomplete coverage of the omphalocele contents with granulations r e q u i r i n g Silon c o v e r a g e , mercurial toxicity, and sudden death from unknown e t i o l o g y / O p e r a t i v e coverage of a huge omphalocele with Silon (whether the intact sac is left in place or removed, or whether the sac is ruptured or not) has resulted in infection, 2 premature separation of the Silon pouch, 2 and even damage to the pouch contents during manual reduction. 12,~s The Gross 3 method of covering the large omphalocele with undermined skin flaps, while not without some immediate problems, has certainly made eventual definitive closure of the anterior abdominal wall a large, time-consuming, multistaged undertaking. ~" ~ Nevertheless, in all cases when successful initial coverage has been accomplished, the result has still been a large skin-covered ventral hernia which requires eventual closure in single or multiple stages. Our new method of nonoperative coverage of large unruptured and ruptured omphaloceles, while not devoid of all problems and though resulting in a large skin-covered ventral hernia, is worthy of clinical consideration because of its relative ease of application, apparent minimal number of problems, and safety. It does resemble previous attempts to cover the amniotic sac with biological dressings. 1,7 Moreover, if this method is of value in treating ruptured omphaloceles, the handling of a difficult emergency problem will be made much easier. Prior to this a p p r o a c h , in our h o s p i t a l s as well as in others 1-7'9,1~the ruptured omphalocele sac was excised and the abdominal contents were either covered with skin flaps, or more recently with a Silon pouch. As demonstrated in the second baby, if an omphalocele sac is ruptured, its removal is not necessary, ~6 because it is possible to close it over its contents. Furthermore, the closure need not be done in the operating room or under general anesthesia. After closure, the Op-Site membrane can be applied as in the first baby. The Op-Site covering is a transparent, skinlike polymer m e m b r a n e , which is flexible, elastic, and nonporous. It is permeable to gases and water vapor and inhibits bacteria. One of its surfaces is adhesive, and though it does stick to the amniotic sac, when this sac liquefies the OpSite does not adhere to the underlying intraab-
EIN AND SHANDLING
dominal contents and does not seem to interfere with gastrointestinal function. Infection does not seem to be any more of a problen than in G r o b ' s m e t h o d o f a q u e o u s or t i n c t u r e c o v e r a g e / This artificial membrane does not absorb most exudate as does a standard ventilated dressing, and the retention of a moist serous exudate provides optimum healing conditions by allowing cells to migrate more quickly. This eliminates scab formation, thus avoiding the distressing problem of adhesion to the wound surface. Although there is the possibility of this exudate becoming a focus of infectiofl, it does help to prevent loss of viable tissue. 17 R e c e n t a d v a n c e s in u n d e r s t a n d i n g the mechanism of wound healing and the effect of the wound environment on the rate and quality of epidermal regeneration have shown that moist conditions can improve the rate of epithelialization. Traditional dressings, however, provide the opposite: dry wound conditions with likely loss of viable tissue, delayed epidermal migration, and scab formation. 18-2o The Op-Site membrane was not removed in the first 3 wk because of possible evisceration due to lack of coverage of the abdominal contents with appropriate granulations. Nonetheless, the manufacturer does recommend that Op-Site-dressed wounds be examined after 48-72 hr for excessive exudate and leakage. This exudate appears as a layer of fluid between the Op-Site and the forming granulations. Such a fluid collection is to be expected and should be drained. If this initial exudate is excessive (and we do not yet know what is to be considered "excessive") or leakage does occur, the Op-Site covering can be reinforced or changed, but not punctured. As the exudation decreases, there is no need to change the Op-Site. The second baby had her initial Op-Site covering first changed on the 17th day and it was subsequently changed several more times during the total 6 wk coverage without any evidence of infection or e v i s c e r a t i o n o f the u n d e r l y i n g c o n t e n t s . T h e r e f o r e , safe r e m o v a l o f the O p - S i t e m e m b r a n e can p r o b a b l y be a c c o m p l i s h e d between 2 and 3 wk. Ideally, the earlier it is removed, the less chance for infection, but one must be concerned about too early removal of Op-Site leaving an evisceration of intraabdominal contents. If that happens, it would be unwise to apply a Silon pouchJ Instead, in two
LARGE OMPHALOCELES WITH POLYMER MEMBRANE
such instances in our hospital, application of Op-Site on top of the eviscerated abdominal contents until granulations developed was successful. Our experience with infection in more than 60 Silon pouches and these two Op-Site-covered babies indicates that sepsis is not adequately controlled by the routine use of antibiotics either systemically or locally.2 Moreover, the
257
use of intravenous nutrition increases the chance of Candida sepsis, especially if a central venous line is present. We use total peripheral parenteral nutrition. Therefore, the sooner the Op-Site membrane can be safely removed, and the shorter the course of antibiotics (given only when necessary), the less the morbidity from sepsis.
REFERENCES
1. Seashore JH, MacNaughton RJ, Talbert JL: Treatment of gastroschisis and omphalocele with biological dressings. J Pediatr Surg 10:9, 1975 2. Rubin SZ, Ein SH: Experience with 55 Silon pouches. J Pediatr Surg 11:803, 1976 3. Gross RE: New method for surgical treatment of large omphaloceles. Surgery 24:277, 1948 4. Gilbert MG, Mencia LF, Brown WT, et al: Staged surgical repair of large omphaloceles and gastroschisis. J Pediatr Surg 3:702, 1968 5. Allen RG, Wrenn EL Jr: Silon as a sac in the treatment of omphalocele and gastroschisis. J Pediatr Surg 4:3, 1969 6. Grob M: Conservative treatment of exomphalos. Arch Dis Child 38:148, 1965 7. Kling S: Massive omphalocele: A method of treatment employing skin allograft. Can J Surg 10:445, 1967 8. Girvan DP, Webster D, Shandling B: The treatment of omphalocele and gastroschisis. Surg Gynecol Obstet 139:222, 1974 9. Firor HV: Omphalocele--An appraisal of therapeutic approaches. Surgery 69:208,1971 10, Shim WKT: Lateral plication of synthetic sac for large gastroschisis and omphalocele defects. J Pediatr Surg 6:143, 1971 11. Schuster SR: A new method in the staged repair of large omphaloceles. Surg Gynecol Obstet 125:837, 1967
12. Vassy LE, Boles ET Jr.: Iatrogenic ileal atresia secondary to clamping of an occult omphalocele. J Pediatr Surg 10:797, 1975 13. Wexler HR, Hailer JA Jr: A non-invasive method for controlled reduction of omphalocele prosthesis. J Pediatr Surg 6:774, 1971 14. Ein SH, Fallis JC, Simpson JS: Silon sheeting in the staged repair of massive ventral hernias in children. Can J Surg 13:127, 1970 15. Boles ET Jr: Staged repair of huge ventral hernias. J Pediatr Surg 6:618, 1971 16. Slim MS: Combined treatment of omphalocele. Surgery 61:314, 1967 17. Lawrence JC: Perinecrotic zone in burns and its influence on healing. Burns 1:197, 1975 18. Winter GD: Healing of skin wounds and the influence of dressings on the repair process in Harkiss KJ (ed): Surgical Dressings and Wound Healing. Bradford University Press, 1971 pp 46-60 19. Winter GD: Epidermal regeneration studied in the domestic pig in Maibach HI, Rovee DT (eds): Epidermal Wound Healing, chap 4. Yearbook Medical, Chicago, 1972, pp71-112 20. Rovee DT, et al: Effect of local wound environment on epidermal healing, in Maibach HI, Rovee DT (eds); Epidermal Wound Healing, chap 8. Yearbook Medical, Chicago, 1972, pp 159-184
CASE REPORTS Case 1 In September 1976, C.E., a 3300-g boy, was born with a large unruptured omphalocele in which liver, spleen, and most of the intestinal tract could be seen through the intact amniotic covering. Intravenous and nasogastric therapy were started, and in the newborn nursery, after the cord was tied and the clamp removed, the omphalocele sac was covered with a polymer membrane, marketed under the name Op-Site.* Gastrointestinal function started on the fifth day. On the seventh day, the baby developed signs and symptoms of sepsis, for which i.v. antibiotics (ampicillin and gentamicin) were given with good results. Fourteen days after the Op-Site covering was applied, one could see the amniotic sac liquefying beneath the transparent membrane and an offensive odor was noted. The abdomen (including the omphalocele) was wrapped with a dry sterile gauze dressing over the polymer membrane. This gauze dressing and the underlying Op-Site were removed 24 days after birth. The amniotic membrane had been replaced by granulation tissue, (covered with a thin purulent exudate) and skin had grown around the omphalocele three-quarters of the way to the granulations. The granulations were cleaned with a local antiseptic (Hygeol) solution, and epithelial coverage was complete within 4 wk. The baby had been discharged 2 wk before the residual ventral hernia was completely covered by skin. The ventral hernia was easily closed in one stage when the baby was 13 mo old.
*Smith and Nephew, Ltd., Lachine, Quebec, Canada. Journal of Pediatric Surgery, Vol. 13, No. 3 (June), 1978
Case 2 In January 1977, N.M., weighing 2200 g was born with a large ruptured omphalocele. The liver, spleen, and most of the gastrointestinal tract were all outside the omphalocele. The baby was immediately operated upon under general anesthesia, the abdominal contents were replaced into the amniotic sac, and the sac was closed with silk sutures. The repaired sac was covered with an antibiotic-impregnated gauze dressing, and several hours later, in the newborn nursery, this gauze dressing was removed and the repaired omphalocele sac was covered with Op-Site. The early postoperative period was very stormy, with episodes of seizure, sepsis, hypocalcemia, hypoglycemia, and cardiac failure. She was given the appropriate treatment, which included assisted ventilatory care, digita/ization, and antibiotics. During this difficult period her neurologic status was questionable but a CT scan showed only cerebral edema. She also had a prolonged gastrointestinal ileus that required nasogastric decompression and peripheral i.v. alimentation. The entire clinical picture slowly improved over a period of weeks. In the meantime, the Op-Site polymer membrane dressing was first changed on the 17th day, and several times thereafter over the next month, each time being covered with dry sterile gauze. By the 6th wk, Op-Site coverage of the omphalocele sac was no longer necessary as granulations had replaced the entire amniotic membrane. These granulations were treated with Hygeol dressings for a few weeks and the baby was discharged home with a large granulation-covered ventral hernia that eventually healed over with skin. This hernia will be repaired when she is between 1 and 2 yr of age.
DISCUSSION
Primary closure of a huge omphalocele is technically impossible, and many methods of immediate coverage of the large intact amniotic membrane sac have been employed. 1 TM All methods (operative and nonoperative) have had their problems, and some have been very difficult to solve. Painting unruptured omphalocele sacs with a tincture or aqueous solution has resulted in many problems: premature rupture of the eschar, sepsis from the frequently found puFrom the Division of General Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada. Presented before the 26th Annual Meeting of the American Academy of Pediatrics, Surgical Section, New York, New York, November6 8, 1977. Address reprint requests to Dr. Sigmund H. Ein, Division of General Surgery, The Hospital'for Sick Children. 9 1978 by Grune & Stratton, Inc. 0022 3468/78/1303-0009501.00/0 255
256
rulent collection beneath the eschar, incomplete coverage of the omphalocele contents with granulations r e q u i r i n g Silon c o v e r a g e , mercurial toxicity, and sudden death from unknown e t i o l o g y / O p e r a t i v e coverage of a huge omphalocele with Silon (whether the intact sac is left in place or removed, or whether the sac is ruptured or not) has resulted in infection, 2 premature separation of the Silon pouch, 2 and even damage to the pouch contents during manual reduction. 12,~s The Gross 3 method of covering the large omphalocele with undermined skin flaps, while not without some immediate problems, has certainly made eventual definitive closure of the anterior abdominal wall a large, time-consuming, multistaged undertaking. ~" ~ Nevertheless, in all cases when successful initial coverage has been accomplished, the result has still been a large skin-covered ventral hernia which requires eventual closure in single or multiple stages. Our new method of nonoperative coverage of large unruptured and ruptured omphaloceles, while not devoid of all problems and though resulting in a large skin-covered ventral hernia, is worthy of clinical consideration because of its relative ease of application, apparent minimal number of problems, and safety. It does resemble previous attempts to cover the amniotic sac with biological dressings. 1,7 Moreover, if this method is of value in treating ruptured omphaloceles, the handling of a difficult emergency problem will be made much easier. Prior to this a p p r o a c h , in our h o s p i t a l s as well as in others 1-7'9,1~the ruptured omphalocele sac was excised and the abdominal contents were either covered with skin flaps, or more recently with a Silon pouch. As demonstrated in the second baby, if an omphalocele sac is ruptured, its removal is not necessary, ~6 because it is possible to close it over its contents. Furthermore, the closure need not be done in the operating room or under general anesthesia. After closure, the Op-Site membrane can be applied as in the first baby. The Op-Site covering is a transparent, skinlike polymer m e m b r a n e , which is flexible, elastic, and nonporous. It is permeable to gases and water vapor and inhibits bacteria. One of its surfaces is adhesive, and though it does stick to the amniotic sac, when this sac liquefies the OpSite does not adhere to the underlying intraab-
EIN AND SHANDLING
dominal contents and does not seem to interfere with gastrointestinal function. Infection does not seem to be any more of a problen than in G r o b ' s m e t h o d o f a q u e o u s or t i n c t u r e c o v e r a g e / This artificial membrane does not absorb most exudate as does a standard ventilated dressing, and the retention of a moist serous exudate provides optimum healing conditions by allowing cells to migrate more quickly. This eliminates scab formation, thus avoiding the distressing problem of adhesion to the wound surface. Although there is the possibility of this exudate becoming a focus of infectiofl, it does help to prevent loss of viable tissue. 17 R e c e n t a d v a n c e s in u n d e r s t a n d i n g the mechanism of wound healing and the effect of the wound environment on the rate and quality of epidermal regeneration have shown that moist conditions can improve the rate of epithelialization. Traditional dressings, however, provide the opposite: dry wound conditions with likely loss of viable tissue, delayed epidermal migration, and scab formation. 18-2o The Op-Site membrane was not removed in the first 3 wk because of possible evisceration due to lack of coverage of the abdominal contents with appropriate granulations. Nonetheless, the manufacturer does recommend that Op-Site-dressed wounds be examined after 48-72 hr for excessive exudate and leakage. This exudate appears as a layer of fluid between the Op-Site and the forming granulations. Such a fluid collection is to be expected and should be drained. If this initial exudate is excessive (and we do not yet know what is to be considered "excessive") or leakage does occur, the Op-Site covering can be reinforced or changed, but not punctured. As the exudation decreases, there is no need to change the Op-Site. The second baby had her initial Op-Site covering first changed on the 17th day and it was subsequently changed several more times during the total 6 wk coverage without any evidence of infection or e v i s c e r a t i o n o f the u n d e r l y i n g c o n t e n t s . T h e r e f o r e , safe r e m o v a l o f the O p - S i t e m e m b r a n e can p r o b a b l y be a c c o m p l i s h e d between 2 and 3 wk. Ideally, the earlier it is removed, the less chance for infection, but one must be concerned about too early removal of Op-Site leaving an evisceration of intraabdominal contents. If that happens, it would be unwise to apply a Silon pouchJ Instead, in two
LARGE OMPHALOCELES WITH POLYMER MEMBRANE
such instances in our hospital, application of Op-Site on top of the eviscerated abdominal contents until granulations developed was successful. Our experience with infection in more than 60 Silon pouches and these two Op-Site-covered babies indicates that sepsis is not adequately controlled by the routine use of antibiotics either systemically or locally.2 Moreover, the
257
use of intravenous nutrition increases the chance of Candida sepsis, especially if a central venous line is present. We use total peripheral parenteral nutrition. Therefore, the sooner the Op-Site membrane can be safely removed, and the shorter the course of antibiotics (given only when necessary), the less the morbidity from sepsis.
REFERENCES
1. Seashore JH, MacNaughton RJ, Talbert JL: Treatment of gastroschisis and omphalocele with biological dressings. J Pediatr Surg 10:9, 1975 2. Rubin SZ, Ein SH: Experience with 55 Silon pouches. J Pediatr Surg 11:803, 1976 3. Gross RE: New method for surgical treatment of large omphaloceles. Surgery 24:277, 1948 4. Gilbert MG, Mencia LF, Brown WT, et al: Staged surgical repair of large omphaloceles and gastroschisis. J Pediatr Surg 3:702, 1968 5. Allen RG, Wrenn EL Jr: Silon as a sac in the treatment of omphalocele and gastroschisis. J Pediatr Surg 4:3, 1969 6. Grob M: Conservative treatment of exomphalos. Arch Dis Child 38:148, 1965 7. Kling S: Massive omphalocele: A method of treatment employing skin allograft. Can J Surg 10:445, 1967 8. Girvan DP, Webster D, Shandling B: The treatment of omphalocele and gastroschisis. Surg Gynecol Obstet 139:222, 1974 9. Firor HV: Omphalocele--An appraisal of therapeutic approaches. Surgery 69:208,1971 10, Shim WKT: Lateral plication of synthetic sac for large gastroschisis and omphalocele defects. J Pediatr Surg 6:143, 1971 11. Schuster SR: A new method in the staged repair of large omphaloceles. Surg Gynecol Obstet 125:837, 1967
12. Vassy LE, Boles ET Jr.: Iatrogenic ileal atresia secondary to clamping of an occult omphalocele. J Pediatr Surg 10:797, 1975 13. Wexler HR, Hailer JA Jr: A non-invasive method for controlled reduction of omphalocele prosthesis. J Pediatr Surg 6:774, 1971 14. Ein SH, Fallis JC, Simpson JS: Silon sheeting in the staged repair of massive ventral hernias in children. Can J Surg 13:127, 1970 15. Boles ET Jr: Staged repair of huge ventral hernias. J Pediatr Surg 6:618, 1971 16. Slim MS: Combined treatment of omphalocele. Surgery 61:314, 1967 17. Lawrence JC: Perinecrotic zone in burns and its influence on healing. Burns 1:197, 1975 18. Winter GD: Healing of skin wounds and the influence of dressings on the repair process in Harkiss KJ (ed): Surgical Dressings and Wound Healing. Bradford University Press, 1971 pp 46-60 19. Winter GD: Epidermal regeneration studied in the domestic pig in Maibach HI, Rovee DT (eds): Epidermal Wound Healing, chap 4. Yearbook Medical, Chicago, 1972, pp71-112 20. Rovee DT, et al: Effect of local wound environment on epidermal healing, in Maibach HI, Rovee DT (eds); Epidermal Wound Healing, chap 8. Yearbook Medical, Chicago, 1972, pp 159-184
