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

This study has been completed.
Sponsor:
Collaborator:
Proxy Biomedical Limited
Information provided by (Responsible Party):
Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01113736
First received: April 12, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Colon Cancer
Rectal Cancer
Biological: AlloMEM™

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Decrease in operative time and a promotion of peritoneal remodeling [ Time Frame: During 3 month ileostomy closure ] [ Designated as safety issue: Yes ]
    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


Enrollment: 10
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Peritoneal Membrane
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 Name: Human Peritoneal Membrane

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113736

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Conor Delaney, MD, PhD
Proxy Biomedical Limited
Investigators
Principal Investigator: Conor P. Delaney, MD, PhD University Hospital Case Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Conor Delaney, MD, PhD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01113736     History of Changes
Other Study ID Numbers: 09-09-23, 09-09-23
Study First Received: April 12, 2010
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Ileostomy
Stenosis
Surgical Wound Dehiscence
Peritoneal
Colorectal Surgery

ClinicalTrials.gov processed this record on November 24, 2014