NCT04916067

Stoma Closure and Reinforcement Trial ll

Stoma Closure and Reinforcement (SCAR)-II Trial: A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Inflammatory Bowel Disease Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.

Conditions

• Ileostomy - Stoma
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DEVICE	Mesh Implantation	Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2021-06-07
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study