Knotless vs Conventional Sutures for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This study compares two standard ways of closing surgical incisions in children and adults with cerebral palsy who are having multilevel surgery on both legs (single-event multilevel surgery, or SEMLS). Each participant serves as their own control: all study incisions on one leg, chosen at random, are closed with knotless barbed sutures, and the matching incisions on the other leg are closed with conventional knotted sutures. All sutures used have an antibacterial (triclosan) coating. The main question is whether knotless barbed sutures shorten the time needed to close each incision. The study also compares wound complications, such as infection and wound opening, and scar appearance, rated from photographs by masked reviewers and by patients or caregivers, over the 6 months after surgery.
Are You a Good Fit for This Trial?
This trial is for children and adults with cerebral palsy who are having multilevel surgery on both legs. Participants must be able to have both types of sutures used during their procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Conventional suture
- Knotless barbed suture
Trial Overview
The study compares two ways of closing surgical wounds: knotless barbed sutures versus conventional knotted sutures. Each person gets one type on one leg and the other type on the other leg, to see which method works better and faster.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Split-body design: in every participant, all study incisions on the limb randomized to this arm are closed in three layers with running knotless barbed sutures: 0 and 2-0 STRATAFIX Symmetric PDS Plus for the deep fascia and subdermal layers, and 3-0 STRATAFIX Spiral Monocryl Plus as a running subcuticular skin closure.
Split-body design: in every participant, the matched study incisions on the contralateral limb are closed in three layers with conventional triclosan-coated sutures: interrupted 0 and 2-0 Coated Vicryl Plus for the deep fascia and subdermal layers, and 3-0 Monocryl Plus as a running subcuticular skin closure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.