Stoma Closure and Reinforcement Trial ll (SCAR-ll)

• ClinicalTrials.gov Identifier: NCT04916067
• Recruitment Status: Recruiting
• First Posted: June 7, 2021
• Last Update Posted: July 17, 2023
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Becton, Dickinson and Company
• Information provided by (Responsible Party): Matthew Z. Wilson, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: June 1, 2021
• First Posted Date: June 7, 2021
• Last Update Posted Date: July 17, 2023
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2021)

Incidence of wound occurrences [ Time Frame: 30 days ]

Incidence 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 1, 2021)

• Incidence of hernia formation [ Time Frame: 30 days, 6 months ]
  The incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and at 6 months from the date of ileostomy closure.
• Quality of Life after mesh implantation [ Time Frame: 30 days, 6 months ]
  Patient will be evaluated with regards to their quality of life outcomes the PROMIS SF 2.0, Ability to Participate in Social Roles and Activities, instrument at 30 days and 6 months from the date of ileostomy closure.
• Bowel Function after mesh implantation [ Time Frame: 30 days, 6 months ]
  Patient will be evaluated with regards to their bowel function using the Colorectal Functional Outcome (COREFO) instrument at 30 days and 6 months from the date of ileostomy closure.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stoma Closure and Reinforcement Trial ll
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Ileostomy - Stoma
• Inflammatory Bowel Diseases

Intervention

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

Study Arms

Experimental: Intervention

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

Intervention: Device: Mesh Implantation

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 1, 2021): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2025
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Matthew Z Wilson, MD, Msc; 603-650-8113; Matthew.z.wilson@hitchcock.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04916067
• Other Study ID Numbers: STUDY02000875
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Matthew Z. Wilson, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Becton, Dickinson and Company

Investigators

• Principal Investigator: Matthew Z Wilson, MD, Msc; Dartmouth-Hitchcock Medical Center

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: July 2023