Stoma Closure and Reinforcement Trial ll

NCT04916067 | Terminated Results DMC FDA Device

• 1 other identifier: STUDY02000875
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ileostomy; hernia; inflammatory bowel disease; IBD

Outcome Measures

Primary Outcomes (1)

• Number of Wound Occurrences

  Number of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.

  30 days

Secondary Outcomes (3)

• Incidence of Hernia Formation

  30 days, 6 months

• Quality of Life After Mesh Implantation

  30 days, 6 months

• Bowel Function After Mesh Implantation

  30 days, 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Device: Mesh Implantation

Interventions

Mesh Implantation DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18years.
• Patient is undergoing closure of loop ileostomy.
• Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy.
• Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery.

You may not qualify if:

• Pre-existing systemic infection at the time of ileostomy takedown
• Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
• Previous abdominal hernia repair with mesh placement
• Concurrent surgical procedures in addition to closure of diverting loop ileostomy
• Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

Sponsors & Collaborators

• Becton, Dickinson and Company: collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep.

  PMID: 32577580 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Hernia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Resource limitations resulted incomplete data on most participants as well as early termination and low total enrollment numbers.

Results Point of Contact

• Title: Dr. Matthew Wilson
• Organization: Dartmouth-Hitchcock Medical Center

Matthew.z.wilson@hitchcock.org

603-650-8113

Study Officials

• Matthew Z Wilson, MD, Msc

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: December 1, 2021
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)