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
Sponsor study identifier
interventional
50
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2026
Actual (reported)October 19, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Wound Closure Time per Incision
Total time, in seconds, to close each study incision, measured during surgery by a research assistant with a stopwatch. Timing starts when final irrigation of the wound is complete and the closing suture is handed to the surgeon responsible for closure, and stops when the final suture is cut; the timer is paused for interruptions unrelated to wound closure. Closure time is compared between knotless barbed and conventional closure within matched incision pairs (the same procedure performed on the left and right limbs).
Day of surgery (intraoperative)
Incidence of Surgical Site Infection
Up to 6 months after surgery (NHSN windows of 30 and 90 days)
Incidence of Wound Dehiscence
Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery
Incidence of Suture Spitting and Other Wound Complications
Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery
Observer-Rated Scar Appearance (Stony Brook Scar Evaluation Scale)
4-6 weeks, 3 months, and 6 months after surgery (6 months is the principal time point)
Patient-Reported Scar Assessment (POSAS Patient Scale)
3 and 6 months after surgery (6 months is the principal time point)
Closure Time per Centimeter of Incision
Day of surgery (intraoperative)
Closure Time Difference by Surgeon Training Level and Procedure Type
Day of surgery (intraoperative)
Suture Use and Cost per Limb
Day of surgery (intraoperative)
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.
Absorbable, triclosan-coated knotless barbed sutures (Ethicon, Inc.) used for running closure of all three layers without knots: 0 and 2-0 polydioxanone for the deep fascia and subdermal layers, and 3-0 poliglecaprone 25 for subcuticular skin closure, placed according to the manufacturer's instructions for use.
UCLA Santa Monica Medical Center
Santa Monica, California, 90404, United States
First Submitted
October 11, 2026
Dynamic, Real-world Learning, Innovative Mobility, and Versatile Exploration (DRIVE): Evaluating a Dose-matched Developmental Powered Mobility Intervention for Young Children With Cerebral Palsy
Absorbable, triclosan-coated conventional sutures (Ethicon, Inc.): interrupted, knotted 0 and 2-0 polyglactin 910 for the deep fascia and subdermal layers, and running subcuticular 3-0 poliglecaprone 25 for the skin, using the institution's standard technique.
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First Posted
October 19, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the published results. Study photographs will not be shared.
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Source: ClinicalTrials.gov.
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