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 Often, the intestines don't fit in the belly because they're swollensilo bag for gastroschisis price  The bag is then placed under gentle traction with the elastic tube provided and adjusted for the most comfortable position

J Matern Fetal Neonatal Med. SILO Bags provide a closed environment for the containment of the exposed intestine and reduce the leakage of serous exudates and. Fortunately, treatment of a left-sided gastroschisis is identical to that of the right-sided form [2]. REFERENCES: 1 Puri A, Bajpai M. 6 This may result from direct protein loss from the intestine into the surrounding amniotic fluid. Gastroschisis affects around 1 in 3,000 babies. SKU Number CIA2251057. The herniated contents, which included the large bowel, small bowel and stomach, were placed inside a 4 cm silo and the ring was inserted within the umbilical defect. Silos are indicated for the protection of the exposed bowel in infants suitable for a bedside staged closure or as temporary protection before a traditional theatre closure. 2022. Chapter 4 Inside out. 0001). the mean waiting time for silo. Gastroschisis silo bag . 9 mm, which yields a calculated volume of 236 mL of the. gestation were treated with open fetal surgery on day 99–101: The gastroschisis was created. Any help would be greatly appericated. 5 Sutureless elastic ring silo for the gastroschisis 749 October 2010 If this was not possible due to concerns aboutA total of 394 neonates with gastroschisis were identified, of which 315 (80%) were classified as simple and 79 (20%) were classified as complex. Gastroschisis is a defect in the abdominal wall. Gastroschisis is a ventral abdominal wall congenital defect with bowel herniation outside the abdominal cavity. Schlatter M, Norris K, Uitvlugt N, DeCou J, Connors R (2003) Improved outcomes in the treatment of gastroschisis using a preformed silo and delayed repair approach. Reduction of gastroschisis & omphalocele without anesthesia at bedside. Search worldwide, life-sciences literature Search. 20201 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available online at the HHS Office for Civil Rights website (opens in new window) . 037. SKU Number CIA2257309. Gastroschisis silo bag . Fortunately, treatment of a left-sided gastroschisis is identical to that of the right-sided form [2]. Source is not about this particular baby’s case but about how gastroschisis is treated. Results: Of 104 patients (50 female, mean birth weight 2. 4) may prevent important complications and is determined to be a better option until stabilization, at which time surgical or sutureless closure is possible without compromise [5, 7]. 00 / Piece | 50 Pieces (Min. Results: 566 neonates with gastroschisis were identified including 224 patients in the IC group and 337 patients in the SP group. Gastroschisis. Babies of mothers under the age of 20 are at an increased risk. Compress the ring and place it into the abdomen, ensuring no contents are trapped between the ring and the inside of the abdominal wall. 1007/s003830050629. 0 cm with their volume ranging from 140 to 1600 mL. Kabeer, Mustafa H. Between 1993 and 1997, 38 children presented with gastro-schisis. There were 27 (33. Table 2. For the staged reduction of gastroschisis and omphalocele Choose from bag openings with a wire spring encapsulated in silicone or a. o Antibiotics not necessary in the absence of culture positivesepsis or clinical instability or for silo presence. Fetal gastroschisis is a congenital defect in a baby's abdominal wall that allows the infant's intestines to protrude through to the outside. The small intestine is often outside the abdomen near the umbilical cord. There are so many different options ranging from primary. Gastroschisis affects around 1 in 3,000 babies. Both of these anomalies were managed separately, with initial placement of a silo bag on the gastroschisis defect and application of topical agents to the omphalocele until complete epithelialization was achieved. Surgical Instrument Disposable Bladeless Trocar with Diamond Tip. Despite advances in the surgical closure of gastroschisis, consensus is lacking as to which method results in the best patient outcomes. 1 ± 5. Early in all pregnancies, the intestine develops inside the umbilical cord and then usually moves inside the abdomen a few weeks later. Disposable Silo Bag for Gastroschisis, Find Details and Price about Surgical Instrument Medical Device from Disposable Silo Bag for Gastroschisis - Microcure (Suzhou). J Pediatr Surg. Spring stays inside the peritoneal cavity and keeps the silo in place. US $9-12 / Piece. Pediatr Surg Int 1999; 15: 442–444, doi: 10. . The total cost is approximately US $10 for each 'silo' bag. Most babies with gastroschisis are born naturally. Gastroschisis is a type of abdominal wall defect. But silo bags cost $240 per bag, making this treatment difficult to access; so, in Uganda, the survival rate for gastroschisis is around 0%. Primary closure is preferred, but, if not feasible, then a silo bag is used to reduce the small bowel, followed by closure. Most often, the infant's abdominal cavity is too small for the intestine to fit back in. 9 N, and 14. S. Preformed spring loaded silo bags have been used in the staged management of abdominal wall defects, especially in gastroschisis and ruptured omphalocele. Medical Silo Bag/ Infant Stoma Care Bag for Gastroschisis Date Posted: 2016-09-01 16:37 From. Gastroschisis happens in about 5 babies out of every 10,000 (0. In: SMALL: Life and Death on the Front Lines of Pediatric. also, the. , Ltd. OMPHALOCELE • Prenatal Diagnosis And Management • Elevation of maternal serum AFP (not as much in gastrisc…. 2), eliminated the need for suturing and meant that the silo could be placed on an awake baby in the NICU. 0001) and shorter time to full feeds (p=0. Placing a spring-loaded silo bag as a bedside procedure without anesthesia on newborns with severe gastroschisis whose viscera cannot be reduced primarily has increased the survival rate (94. thdonghoadian. Prolonged use of the silo, however, can lead to pressure necrosis around the silo ring. 800. U. MD. The bowels are not contained in a covering but are exposed to the amniotic fluid during pregnancy then the air when your baby is born. Size. 5%) by staged silo repair, 14 (41. Fetal MRI predicted silo bag treatment in patients with gastroschisis in 90% of the cases in our cohort and might facilitate prenatal counseling and treatment planning. 73. Gastroschisis silo bag A sterile, synthetic polymer bag intended to contain and isolate the protruding intestine of a neonate with. let the water move out of the intestines so they shrink to normal sizeBackground Gastroschisis mortality in sub-Saharan Africa (SSA) remains high at 59–100%. gastroschisis ผศ. o Secure silo to overhead warmer with trach string ties to keep silo contents completely perpendicular to infant abdomen. We used self-produced. A sutured silo had traditionally been used until 1995 when the use of a spring-loaded silo was reported. Often, the intestines don't fit in the belly because they're swollen. Silo inaccessibility contributes to this disparity. 3 a]. Methods: Neonates with gastroschisis were enrolled at Songklanagarind Hospital. 1999; 15:442–4. 01 ± 0. 9. , Ltd. Design Population based cohort study of all liveborn infants with gastroschisis born in the United Kingdom and Ireland from October 2006 to March 2008. The purpose of this meta-analysis was to compare short-term outcomes associated with primary fascial closure and staged repair with a silo in patients with gastroschisis. (%) of Patients P Valuea 1998-2003 (n=45) 2004-2007 (n=46) Wound infection 1 (2) 4 (9) . Silicone Silo Bag Description Diameter Length Price Order for Doctor: Patient: Surgery Date: Catalog No: Quantity: Author: Ray Hennessy1st placement of silo(49605): Weighing 1. 63. Advanced Search Coronavirus articles and preprints Search examples: "breast cancer" Smith JIntroduction: General surgery residents often feel unprepared for rotations on pediatric surgical services as case volume and experience performing pediatric procedures may be inadequate for high acuity, low volume procedures. 2%) staged closures. The organs usually move inside the body before the baby is born. The incidence of gastroschisis is approximately 1 per 4000 live births [ 1] and is rarely associated with other congenital anomalies. mean birth weight was 2. 7 This silo enables placement of the ring inside the abdominal cavity through the open gastroschisis defect, while the bowel is placed inside the bag. Resolution of bowel edema prior to return of the bowel into the abdominal cavity. If an omphalocele or gastroschisis is too large to impair immediately what will they do? Click the card to flip 👆. 73 is a billable medical code that can be used to indicate a diagnosis on a reimbursement claim, however, 756. Some of the studies intervened on the perioperative care and resuscitation while using local modification of silo bags. 1007/s003830050629 [Google Scholar] 17. Therefore, in this article, we present a method for creating a preformed silo bag by utilising readily available disposable equipment in secondary or tertiary hospitals. 10, 21 Gastroschisis defects commonly have a diameter of 1. Use minimal tension in securement. let the water move out of the intestines so they shrink to normal sizewith Gastroschisis Silo Units 1-4, Rivington View Business Park, Station Road, Blackrod, Bolton BL6 5BN, UK Telephone: +44(0)1204 695050 SBMKT002. The bowel then develops outside of the baby’s body in the amniotic fluid. A temporary stoma was brought out at a convenient place on the silo sheath and fixed with sutures. Gastroschisis is a relatively uncommon condition that occurs in approximately 1 in 5,000 live births. Schuck RJ, Sturm B, Deeg KH, et al: Intra-abdominal pressure hemoderivative bag in the treatment of gastroschisis. Microcure is trying to expand silo use for Gastroschisis across Africa. The closed end of the silo bag can be suspended above the patient . Both omphalocele and gastroschisis are often first diagnosed through prenatal sonography [7]. This allows gravity to help the intestine to slip back into the abdomen. Disposable with CE Certificate Surgical Device Wound Protector Surgical Retractor. Soft, Pliable, Transparent Material Range of Sizes & Configurations Spring-Loaded Since 1997, clinicians around the world have used the Bentec Silo Bag for staged reductions of congenital ventral wall defects. mean birth weight was 2. Abstract Background We report a prospective randomized trial comparing primary closure (PC) to bedside silo and delayed closure. 2009; 144:516–519. o Assessment post-silo placement:Lubricate the silo with warm normal saline and place the eviscerated intestines into the bag, ensuring the mesentery is not twisted. Approximately 16,000 babies are born with gastroschisis across sub-Saharan Africa each year with a mortality rate of 75-100%. 4 ( median 14. Objective To describe one year outcomes for a national cohort of infants with gastroschisis. Babies of mothers under the age of 20 are at an increased risk. While spring-loaded silo bags have the best outcomes, improvised silos and sutured urine bags provide alternative solutions for delayed closure in LICs. Yakea EJ, Kulau BD, Mulu J, Duke T. Am Surg. Mychaliska ⁎ Section of Pediatric Surgery, Department of Surgery, The University of Michigan Medical School and The C. Keywords: Gastroschisis, limited resources, medical equipment, silo bag Address for correspondence: Dr. C. A spring-loaded silicone silo was placed at birth. Discussion. Compress the ring and place it into the abdomen, ensuring no contents are trapped between the ring and the inside of the abdominal wall. management outcome of gastroschisis using our improvised silo, and performing an extended right hemicolectomy. Staged Closure with Silo (most defects) Place peripheral arterial line (PAL) prior to procedure with initial infusion of isotonic amino. ComplicationsView the sourcing details of the buying request titled Medical Silo Bag/ Infant Stoma Care Bag for Gastroschisis, including both product specification and requirements for supplier. Silo bags are expensive, and different sizes are needed depending on the gastroschisis size. RECEIVED: 7 August 2021. Survival has dramatically improved to greater than 90% over the past 6 decades, due to improved techniques to close the abdominal wall defect and advances in neonatal care (3, 4, 5). Bentec has been. Treatment is a surgery that slowly returns the intestines to the. Brand Name: Ventral Wall Defect Silo Bag Version or Model: GR74089-04 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BENTEC MEDICAL OPCO, LLC Primary DI Number:. DOI link, PMid:10798139 2 Owen A, Marven S, Bell J. Primary closure is preferred, but, if not feasible, then a silo bag is used to reduce the small bowel, followed by closure. It occurs when a child’s abdomen does not develop fully while in the womb. There were no differences seen between PC and DC in LOS, time to enteral feeds, or ventilator times, and none of the patients in this series developed abdominal compartment syndrome after closure. Gastroschisis is a type of abdominal wall defect. Order: 100 Pieces. Bedside placement of a spring-loaded silo (SLS) (Ventral Wall Defect Silo Bags; Bentec Medical, Woodland, California; Figure 1) was first described in 1995 and was implemented at our institution in January 2004. Through the work we are doing we are trying to expand silo use for Gastroschisis across #Africa and other low-income #developingcountries. Thirty-two (84. List Price $729. Gastroschisis traditional management is the primary operative closure surgery (POCS), but the sutureless silo approach (SSA), a novel alternative, gains wide acceptance in the developed countries and across nations. Primary closure is preferred, but, if not feasible, then a silo bag is used to reduce the small bowel, followed by closure. OVERSTOCK SALE — Shop IV Products,. Kim, Ryan P. silo (SLS), transparent Silastic silo, body bag, or. This is a 17cm long polyurethane bag with a neck diameter of 7. Gastroschisis is traditionally managed by emergency primary closure, with a temporary silo reserved for large defects unable to be closed primarily. I have attached the procedure op note:. Ventilatory Support in the Patients With Gastroschisis Staged Repair Primary Closure (n = 20) (n = 4) Ventilation requirement 4 2 Preoperative intubation 1 0 Duration (no. Placing a spring-loaded silo bag as a bedside procedure without anesthesia on newborns with severe gastroschisis whose viscera cannot be reduced primarily has increased the survival rate (94. by a 1. 5 ) which require suturing of edge of ba g to fascia under. Indications and Benefits. Notify PIPER (1300 137 650) when the baby is born (do not wait until stabilisation is. thdonghoadian. Some studies have shown gastroschisis managed with a silo and delayed closure 1 3 increased the neonate's time on the ventilator, time to initiate enteral feeding, time to full enteral feeding. Order). A case report. The intestine is placed inside the silo bag and the ring is placed under the fascia. Silo bags are preformed silicone bags that are used for children with gastroschisis (abdominal wall defect). Gastroschisis. พญ. J Pediatr Surg. 50):. A congenital condition is a condition that your baby is born with. 9. let the water move out of the intestines so they shrink to normal sizeBackground: We report a prospective randomized trial comparing primary closure (PC) to bedside silo and delayed closure (DC) for babies with gastroschisis. Put the baby's lower half and the intestines in a special plastic bag to keep the intestines from losing too much water and to reduce heat loss. 4%, while patients with complex gastroschisis have a mean LOS of 85 ± 60 days and a mortality rate of 9. J Surg Res, 255 (2020), pp. View PDF View article. Dr. we are billing an unlisted procedure for silo placement with a resection of the small intestine. 1. Silo Bags are indicated for the protection of the exposed bowel in infants and are. Gastroschisis is a centrally located, full thickness abdominal wall defect ___ that results in the incomplete formation of the abdominal wall. 1053/j. List Price $ 849. The pri mary goal ofSilo pouch formation is a standard procedure to prevent compartment syndrome in gastroschisis. Quick Details. SB06. Initially, silos were used in cases that could not be closed primarily although in time, reports of routine, awake silo placement in the. The abdominal wall defect is quite small, and I struggled to get a 4 cm silo placed. The silo is supported over the baby's belly (see Picture 1). 018), closure by DOL4 showed a trend toward earlier feeding (p=0. For example, we were told that gastroschisis affects roughly 1/5000 pregnancies. Most often, the infant's abdominal cavity is too small for the intestine to fit back in. Regarding the silo treatment: In the past, a silo was created using sterile plastic bags and typically sutured to the abdominal wall. . Gastroschisis can be detected by a routine prenatal ultrasound during a mother’s pregnancy, usually around 18-20 weeks gestation. ICD-9-CM 756. Gastroschisis refers to an opening, or ‘hole’, in the abdominal wall. silo bag. S. The care team gradually tightens the silo as the intestines return to normal size. Lobo, Anne C. The pri mary goal ofA newborn female that was diagnosed with gastroschisis underwent placement of a silo at bedside. Silo bags are synthetic, flexible silicone bags used to cover and protect the bowel of neonates born with gastroschisis. Most babies only need one operation. This study compared the outcomes of these two techniques. This means the baby weighs less than we would expect for the gestational age. When this is not feasible, a silo is required to progressively reduce the organs and perform a deferred closure of the wall. 01. Babies with gastroschisis can spend anywhere from two weeks up to three to four months in the hospital. As a consequence, the intestines and organs return to the abdomen within 5–10 days [ 4 ]. 1 Proposed benefits of this device have included fewer days in need of ventilatory support, decreased incidence of pulmonary. Sometimes, gastroschisis can be repaired surgically at birth. 5 hours. Investigations. 4. 1% (13 cases). The care team gradually tightens the silo as the intestines return to normal size. "Multidisciplinary Development of a Low-cost Gastroschisis Silo - Free download as PDF File (. Most often, the infant's abdominal cavity is too small for the intestine to fit back in. With SILO Bags, HMC Group approaches the world of congenital gastrointestinal anomalies, offering a range of. The condition happens early in pregnancy when the baby’s abdominal wall doesn't close the way it should. Silos yielded a diameter of 5. 4 N, respectively, compared with the seal of the current standard-of-care silo of 41. Jamie. Bedside placement of spring-loaded silo Surgical placement of silo Primary closure Figure 2. Currently, tertiary hospitals in low-income countries experience great difficulty in purchasing these bags. vn September 27, 2023 Top images of big bag silo by website es. Our multidisciplinary American and Ugandan team designed and bench-tested a low-cost (LC) silo that costs < $2 and is constructed from locally available materials. Arch Surg. allow the intestines to slowly move into the belly The care team gradually tightens the silo as the intestines return to normal size. Placing a spring-loaded silo bag as a bedside procedure without anesthesia on newborns with severe gastroschisis whose viscera cannot be reduced primarily has increased the survival rate (94. Placing a spring-loaded silo bag as a bedside procedure without anesthesia on newborns with severe gastroschisis whose viscera cannot be reduced primarily has increased the survival rate (94. 77(1. Currently, tertiary. 00-13. Gastroschisis is when a baby is born with the intestines, and sometimes other organs, sticking out through a hole in the belly wall near the umbilical cord. Appointments: 714-364-4050. 7%, 42. The most common interventions in HICs are primary closure in the operating room or use of a preformed silo with gradual intestinal reduction and delayed closure, often at the cotside without general anaes-thetic. Silo medicina pre-formed I icon e sil os @medicina Silo Silo An innovative surgical solution for infants with Gastroschisis medicina p re-formed s ilicone s mos medicna preomed silicone silos Medicina Silos are pre-formed silicone bags indicated for use in infants with gastroschisis. We hypothesized that patients undergoing SP for ≤5 days would have largely equivalent outcomes compared to IC patients. Gastroschisis is the most common congenital abdominal wall defect. The text includes an introduction that outlines the indications, risks, alternatives, essential steps, needed. By day of life (DOL) 22, minimal visceral contents had been reduced, and the silo was difficult to maintain due to the large size of the fascial defect and loss of abdominal. Silos are indicated for the protection of theSilo bags are expensive, and different sizes are needed depending on the gastroschisis size. outcomes. Specialty: Pediatric Surgery. Primary defect closure is the surgical treatment of choice in gastroschisis. 08. 3% [ 104 ]. This article provides an overview of selected neonatal surgical emergencies, including congenital diaphragmatic hernia, meningomyelocele, omphalocele, and gastroschisis. Product Code. 1. Sell Unit EACH. Median silo size was 4 cm, and time of application was 2. 8 per 10,000 to 4. 73 should only be used for claims with a date of service on or before September 30, 2015. Spring-Loaded Silicone Silo Bag - 10cm Opening Diameter. 026, Chi. With this CE mark, Bentec will be able to offer outside the U. Medicina Silo Bags are pre-formed silicone bags indicated for use in infants with gastroschisis. J Pediatr Surg 48:845–857. also, the only efficient and effective solution available to manage Gastroschisis or Omphalocele, where primary reduction & closure of these defects is not feasible. Hawkins RB, Raymond SL, St Peter SD, Downard CD, Qureshi FG, Renaud E, Danielson PD, Islam S. The spring-loaded ring maintains the stability of the silo, and does not require sutures. doi: 10. The iron + sewn seal, sewn seal, and ironed seal on the silos yielded tensile strengths of 31. Instead, a "silo" or sterile bag will be used for the intestines. 9 Advocates of using a preformed silo claim that the spring-loaded silo is easy to install. Bentec Medical GR74089-02, BAG, SILO VENTRAL WALL DEFECT, 7. Reviewing the unit’s data over 10 years (1 April 2009 to 31 March 2019) revealed that 132 infants were admitted with a diagnosis of gastroschisis; on average 13 infants per year (range = 7-20). This technique was described by Fisher et al in 1985. The silo is a bag that protects the bowels. They are transparent, which enables clinicians to visualise bowel colour and allows for gentle reduction until closure. Silo bags are synthetic, flexible silicone bags used to cover and protect the bowel of neonates born with gastroschisis. 1% for high-, middle-, and low-income countries, respectively . 1%, 16/17, 2004–2008) of infants with severe gastroschisis in comparison to our previous experience (60. The silo is supported over the baby's belly (see Picture 1). We performed a systematic review and meta-analysis of the literature comparing use of a PFS with alternate treatment strategies. Gastroschisis potential risk factors include young maternal age, cigarette smoking, aspirin use, use of vasoconstrictive and recreational drugs, and maternal genitourinary infections . 101 Corpus ID: 54692781; Management of gastroschisis using standard urobag as silo @inproceedings{Gupta2017ManagementOG, title={Management of gastroschisis using standard urobag as silo}, author={Rajesh Gupta. Billable Thru Sept 30/2015. Seminars in pediatric surgery. 50. Category: Silo Bags are preformed silicone bags indicated for use in infants with gastroschisis. 13). What Is Gastroschisis? Gastroschisis is when a baby is born with the intestines sticking out through a hole in the belly wall near the belly button. Key findings in gastroschisis (see Fig. Product Description. We asked for a #10 silo, in which we placed the intestine and placed it underneath the fascia. which compared primary repair with staged closure with silo in patients with gastroschisis showed that in studies with the least amount of bias, silo. The opening can be small or large, and in some severe cases, the stomach and/or liver can also extend outside the body. edu. 7. 7%). 2015 ICD-9-CM Diagnosis Code 756. 8. The closed end of the silo bag can be suspended above the patient . Peds unit 2 GI and GU. Infants have a high proportion of intrauterine growth restriction. The silo was. They demonstrated that the low-cost silo. One hundred fifty infants were included, and 139 (92. In general, affected infants do not have other life-threatening anomalies, and surgical management. They exclude delivery charges and customs duties and do not include additional. 27 for predicting silo bag treatment. 42. 13 per 10,000 in the previous few decades . Complex gastroschisis was diagnosed in. There were 12 patients who fell into the urobag group, 6 patients diagnosed as having gastroschisis and ruptured omphalocele each. We reduced part of the herniated viscera Fig. Treatment for gastroschisis and its morbidity and mortality rates vary widely both on a local and global level . Eligible gastroschisis patients were applied with silo bag, gradual reduction of abdominal viscera and elective abdominal wall closure. About 1,800 babies born in the United States are born with gastroschisis. A gastroschisis silo allow the intestines to slowly move into the belly. Final result after fascial closure. • For bedside silo-placement / closure, recommend placing peripheral IV, pulse oximeter, nasal cannula (in case supplemental oxygen is required), and an orogastric tube (which should be suctioned manually during reduction of bowel). PMCID: PMC7765881. 0 and 10. Silos yielded a diameter of 5. Baby with gastroschisis showing intestine developed outside the body. Gastroschisis is when a baby is born with the intestines sticking out through a hole in the belly wall near the umbilical cord. Mustafa Kabeer is a board-certified pediatric surgeon at CHOC, performing all types of general surgery and specializing in pectus excavatum (sunken chest), lung resection, hernia and robotic surgery. Gastroschisis Silo bag Surgical latex gloves ABSTRACT Gas troschi sis is a con gen i tal ab dom i nal wall de fect with in ci dence of 1 in 4000 live births. Silicone Silo Bags For the staged reduction of gastroschisis and omphalocele. Pediatric omphalocele and gastroschisis (abdominal wall defects). 05]. MD. STAGED SILO REPAIR OF GASTROSCHISIS 487 Table 2. Sell Unit EACH. The bowel is quickly inspected for signs of ischemia or a tight fascial ring then covered with a plastic bag over the torso (“bowel bag”) to reduce fluid losses for transport to the NICU. The University of Sydney, Locked Bag 4001, Westmead, Sydney, NSW 2145, Australia. Gastroschisis refers to a rare birth problem that is characterized by a specific defect affecting the anterior portion of the abdominal wall, in which the abdominal intestinal contents are noted to be freely protruding outside a baby’s body. Purchase Qty. If so, the surgeon usually arranges the intestines in a bag called a silo to:. In the absence of standard silos we decided to use latex surgical gloves as a silo bag. Silo Bags are indicated for the protection of the exposed bowel in infants. Materials and methods: Patients were randomized to PC versus DC. Part Number Bentec Medical GR74089-05.