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Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy

18 Years
Open (Enrolling)
Colon Cancer, Rectal Cancer

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Trial Information

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.

Inclusion Criteria:

- Between 18 - 85 years old at the time of ileostomy formation

- Scheduled to undergo planned diverting loop ileostomy

Exclusion Criteria:

- Patients undergoing emergency surgery

- Patients with abdominal or pelvic abscess present at time of initial surgery

- Patients with a history of pulmonary embolism or deep vein thrombosis (DVT) within 1
year of surgery

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.

Outcome Description:

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.

Outcome Time Frame:

Average 1 hour during formation of ileostomy

Safety Issue:


Principal Investigator

Conor P. Delaney, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

July 2013

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Ileostomy
  • Stenosis
  • Surgical Wound Dehiscence
  • Peritoneal
  • Colorectal Surgery
  • Colonic Neoplasms
  • Rectal Neoplasms



University Hospitals Case Medical Center Cleveland, Ohio  44106