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NCT07880197
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Conditions: Cerebral Palsy
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University of California, Los Angeles
Location: UCLA Santa Monica Medical Center Santa Monica California
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07880197). StuddyBuddy aggregates publicly available trial information.