Clinical trial · Interventional
Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy
Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy
NCT01113736CI-TRIAL-00058458AlloMemcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AlloMEM™ | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Human Peritoneal Membrane: AlloMEM™
- description
- 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.
- interventionNames
- Biological: AlloMEM™
Primary outcomes (1)
- measure
- If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
- timeFrame
- Average 1 hour during formation of ileostomy
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDJin 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
- DERIVEDKeller 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