Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy (AlloMem)

May 6, 2022 updated by: University Hospitals Cleveland Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Human Peritoneal Membrane: 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.
Biological: AlloMEM™
To investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients.
Other Names:
  • Human Peritoneal Membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
Time Frame: 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.
Average 1 hour during formation of ileostomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in operative time and a promotion of peritoneal remodeling
Time Frame: 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
During 3 month ileostomy closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Proxy Biomedical Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (ESTIMATE)

April 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-09-23 (OTHER: University Hospitals Case Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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