This study is not yet accepting patients

Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery

a study on Cerebral Palsy

Summary

Location
at Santa Monica, California
Dates
study started
study ends around
Principal Investigator
by Soroush Baghdadi, MD

Description

Summary

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.

Official Title

The AC/DCP Trial: Assessment of Closure, Dehiscence, and Aesthetics in Cerebral Palsy Multilevel Surgery. A Randomized, Double-Blinded, Split-Body Trial of Knotless Tissue Control Devices Versus Conventional Suture

Keywords

Cerebral Palsy, Single-Event Multilevel Surgery, Wound Closure, Knotless barbed suture, Knotless Barbed Suture Closure

Eligibility

You can join if…

  • Diagnosis of cerebral palsy.
  • Children and adults of any age.
  • Scheduled for bilateral single-event multilevel surgery (SEMLS) that includes at least two matched procedures (the same procedure performed on both limbs), each requiring an incision longer than 3 cm.
  • Patient and/or legally authorized representative willing and able to provide informed consent, with assent from the patient when appropriate, and to complete follow-up through 6 months after surgery.

You CAN'T join if...

  • Previous scars at planned incision sites.
  • Pre-existing skin or limb conditions on one side only that could affect wound healing or scar appearance.
  • Known allergy or hypersensitivity to any suture material used in the study (polyglactin 910, poliglecaprone 25, or polydioxanone) or to triclosan.
  • Active skin infection or open wound at or near a planned incision site at the time of surgery.
  • Participation in another interventional study that could affect wound healing or scar formation.

Location

  • UCLA Santa Monica Medical Center
    Santa Monica California 90404 United States

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07880197
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated