Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

NCT01113736 | Completed Phase 1 DMC

• 1 other identifier: 09-09-23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Ileostomy; Stenosis; Surgical Wound Dehiscence; Peritoneal; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Decrease in operative time and a promotion of peritoneal remodeling

  During 3 month ileostomy closure

Study Arms (1)

Human Peritoneal Membrane: AlloMEM™

EXPERIMENTAL

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™

Interventions

AlloMEM™ BIOLOGICAL

To investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients.

Also known as: Human Peritoneal Membrane

Human Peritoneal Membrane: AlloMEM™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 - 85 years old at the time of ileostomy formation
• Scheduled to undergo planned diverting loop ileostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Proxy Biomedical Limited: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Jin J, Voskerician G, Hunter SA, McGee MF, Cavazzola LT, Schomisch S, Harth K, Rosen MJ. Human peritoneal membrane controls adhesion formation and host tissue response following intra-abdominal placement in a porcine model. J Surg Res. 2009 Oct;156(2):297-304. doi: 10.1016/j.jss.2009.04.010. Epub 2009 May 13.

  PMID: 19628227 BACKGROUND

• Keller DS, Champagne BJ, Stein SL, Ermlich BO, Delaney CP. Pilot study evaluating the efficacy of AlloMEM for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy. Surg Endosc. 2013 Oct;27(10):3891-6. doi: 10.1007/s00464-013-3004-6. Epub 2013 May 14.

  PMID: 23670746 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Constriction, Pathologic; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Conor P. Delaney, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 30, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

US (1)