Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

Phase 1

Completed

• Conditions: Colon Cancer; Rectal Cancer
• Interventions: Biological: AlloMEM™

• Registration Number: NCT01113736
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Peritoneal Membrane: AlloMEM™	AlloMEM™	For use as a homologous tissue where native peritoneum is absent or traumatized. 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.

Primary Outcome Measures

Name	Time	Method
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.	Average 1 hour during formation of 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.

Secondary Outcome Measures

Name	Time	Method
Decrease in operative time and a promotion of peritoneal remodeling	During 3 month ileostomy closure	The objective of this study is therefore, to investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States