Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy
A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites
after abdominal surgeries. Major complications from creation and subsequent closure of a
temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation,
intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO)
was the most common complication. SBO is caused by adhesions in the surgical site, with
narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions
may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to
close the ileostomy is complicated by the presence of adhesions which make dissection of the
ileostomy difficult, and increase the risk of injury of the small intestine during
dissection, prolonging the operation time in an effort to minimize risk to the patient.
AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA)
for use as a homologous tissue where native peritoneum is absent or traumatized. The
AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA.
AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft
tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is:
minimally manipulated; intended for homologous use only; does not involve the combination of
cell or other tissues, and does not rely on the metabolic function of cells for its primary
function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal
adhesions and provides the biological framework for peritoneal remodeling. By decreasing
adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy
closure and the risk of enterotomy or seromyotomy would be reduced. The combination could
lead to decreased complication rates and therefore decreased morbidity for the surgical
patients requiring an ileostomy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
Change in adhesion formation will be analyzed via the primary outcome of ileostomy mobilization time during ileostomy closure and the secondary outcome of an adhesion grading scale.
Average 1 hour during formation of ileostomy
Conor P. Delaney, MD, PhD
University Hospital Case Medical Center
United States: Institutional Review Board
|University Hospitals Case Medical Center||Cleveland, Ohio 44106|