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

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

Age range

Not specified

Sex

All

Healthy volunteers

No

Interventions

• Device
  Knotless barbed suture

  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.

• Device
  Conventional suture

  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.

Location