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Bioresorbable Mesh
Mesh Implantation for Hernia Prevention After Ostomy Closure (SCAR-ll Trial)
N/A
Recruiting
Led By Matthew Z Wilson, MD, Msc
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 6 months
Awards & highlights
SCAR-ll Trial Summary
This trial is testing a new technique to see if it reduces the formation of hernias at sites of ostomy closure.
Who is the study for?
This trial is for adults over 18 with Inflammatory Bowel Disease who are undergoing closure of a loop ileostomy after bowel resection. Candidates should be suitable for surgery as assessed by a surgeon. Those with additional surgeries, cirrhosis, chronic renal failure on dialysis, collagen disorders, previous mesh hernia repairs or systemic infections at the time of takedown aren't eligible.Check my eligibility
What is being tested?
The study tests a new technique using monofilament bioresorbable mesh to reinforce abdominal wall defects post-ileostomy closure against standard methods. The goal is to see if this can reduce hernia formation by reinforcing the area where the stoma was located.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk due to surgery and foreign material (mesh), possible allergic reactions to materials used in the mesh, and complications related to improper healing or mesh integration.
SCAR-ll Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
A surgeon has approved me for surgery.
Select...
I am having surgery to close my temporary ileostomy.
Select...
I have inflammatory bowel disease and had surgery to create an opening for waste to leave my body.
SCAR-ll Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of wound occurrences
Secondary outcome measures
Bowel Function after mesh implantation
Incidence of hernia formation
Quality of Life after mesh implantation
SCAR-ll Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesh Implantation
2006
N/A
~100
Find a Location
Who is running the clinical trial?
Becton, Dickinson and CompanyIndustry Sponsor
70 Previous Clinical Trials
88,566 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,319 Total Patients Enrolled
Matthew Z Wilson, MD, MscPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to repair a hernia in my abdomen using mesh.I have cirrhosis, need dialysis for kidney failure, or have a collagen disorder.My ileostomy closure was not done through the old stoma site.I am older than 18 years.A surgeon has approved me for surgery.I do not have an ongoing infection at the time of my ileostomy reversal surgery.I am having surgery to close my temporary ileostomy.I am having surgery to close a loop ileostomy and may have other surgeries at the same time.I have inflammatory bowel disease and had surgery to create an opening for waste to leave my body.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are enrolled in this research endeavor?
"Affirmative. Clinicaltrials.gov shows that this experiment, initially posted on December 1st 2021, is actively seeking participants. A total of 20 volunteers must be found at one location for the study to progress forward."
Answered by AI
Is there room for additional participants in this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov confirms that the trial, which was first announced on December 1st 2021, is still active and requires 20 participants at a single site for completion."
Answered by AI
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