Cerebral PalsyNCT07880197
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
A study testing Knotless barbed suture and Conventional suture in people with Cerebral Palsy, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Knotless barbed suture and Conventional suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA Santa Monica Medical Center
Santa Monica, California, 90404
Yman Kamgaing Wappi, B.S., ykamgaingwappi@mednet.ucla.edu
About this study
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
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.
- Conditions
- Cerebral Palsy
- Being tested
- Knotless barbed suture, Conventional suture
- Keywords
- Single-Event Multilevel Surgery, Wound Closure
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knotless barbed sutureDevice
Also called STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device, STRATAFIX Spiral Monocryl Plus Knotless Tissue Control Device
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.
Conventional sutureDevice
Also called Coated VICRYL Plus Antibacterial Suture, MONOCRYL Plus Antibacterial 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.
| Study group | Role | What they receive |
|---|---|---|
| Knotless Barbed Suture Closure | Experimental | 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. Receives: Device: Knotless barbed suture |
| Conventional Suture Closure | Active comparator | 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. Receives: Device: Conventional suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day of surgery (intraoperative)
Secondary outcomes (7)
Incidence of Surgical Site Infection
Proportion of study incisions with a surgical site infection, classified as superficial incisional, deep incisional, or organ/space infection using the CDC National Healthcare Safety Network (NHSN) definitions. Superficial infections are counted within 30 days and deep incisional and organ/space infections within 90 days of surgery; wound infections diagnosed later, through the 6-month visit, are also recorded.
Measured: Up to 6 months after surgery (NHSN windows of 30 and 90 days)
Incidence of Wound Dehiscence
Proportion of study incisions with separation of the wound edges after closure, classified as superficial (skin and subcutaneous tissue) or deep (involving the fascia), with the management required recorded.
Measured: Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery
Incidence of Suture Spitting and Other Wound Complications
Proportion of study incisions with suture spitting (extrusion of suture material through the skin or incision) or other wound events: hematoma, seroma, delayed wound healing, suture granuloma, or local hypersensitivity reaction.
Measured: Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery
Observer-Rated Scar Appearance (Stony Brook Scar Evaluation Scale)
Scar appearance of each study incision scored from standardized photographs by two independent reviewers masked to allocation. The Stony Brook Scar Evaluation Scale rates width, height, color, suture marks, and overall appearance as 0 or 1 each, for a total score from 0 (worst) to 5 (best); the mean of the two reviewers' scores is used.
Measured: 4-6 weeks, 3 months, and 6 months after surgery (6 months is the principal time point)
Patient-Reported Scar Assessment (POSAS Patient Scale)
Patient- or caregiver-reported assessment of each study incision using the patient scale of the Patient and Observer Scar Assessment Scale (POSAS). Six items (pain, itching, color, stiffness, thickness, and irregularity) are each rated from 1 (like normal skin) to 10 (worst imaginable) and summed to a total from 6 to 60; lower scores indicate a better scar. The overall opinion of the scar is rated separately from 1 to 10.
Measured: 3 and 6 months after surgery (6 months is the principal time point)
Number of Device-Related Events
Number of intraoperative device problems (suture breakage, needle detachment, or loss of tissue hold) and postoperative device-related events (suture extrusion, suture granuloma, or hypersensitivity reaction) for each closure method.
Measured: From surgery through 6 months after surgery
Projected Closure Time Saved per Surgical Case
For each participant, the within-pair differences in closure time (conventional minus knotless barbed closure) summed across all matched incision pairs, reported in minutes per case and converted to estimated operating room cost (US dollars) using published per-minute operating room costs.
Measured: Day of surgery (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-body (within-participant) randomized design. Each participant has at least two matched incision pairs, defined as the same procedure performed on both lower limbs during single-event multilevel surgery. One limb is randomized 1:1 (computer-generated sequence, permuted blocks) to knotless barbed suture closure for all of its study incisions, and the matched incisions on the contralateral limb are closed with conventional sutures. Every participant therefore contributes incisions to both arms; the matched incision pair is the unit of analysis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soroush Baghdadi, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880197
- Sponsor's protocol ID
- IRB-26-0744
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results. Study photographs will not be shared.