An interventional study of Knotless barbed suture and Conventional suture in Cerebral Palsy, sponsored by University of California, Los Angeles. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.
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Exclusion Criteria:
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.
Device: Knotless barbed suture
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.
Device: Conventional 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.
Also known as: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device, STRATAFIX Spiral Monocryl Plus Knotless Tissue Control Device
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.
Also known as: Coated VICRYL Plus Antibacterial Suture, MONOCRYL Plus Antibacterial Suture
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).
Time frame: Day of surgery (intraoperative)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day of surgery (intraoperative)
Closure Time per Centimeter of Incision
Closure time in seconds divided by incision length in centimeters, with length measured using a sterile ruler immediately before closure; compared between closure methods within matched incision pairs.
Time frame: Day of surgery (intraoperative)
Closure Time Difference by Surgeon Training Level and Procedure Type
Within-pair difference in closure time (seconds) analyzed according to the closing surgeon's level of training (attending surgeon, fellow, or resident) and the type of procedure.
Time frame: Day of surgery (intraoperative)
Suture Use and Cost per Limb
Number, type, and acquisition cost (US dollars) of suture packages used to close the study incisions on each limb.
Time frame: Day of surgery (intraoperative)
Plan to share: Yes — De-identified individual participant data underlying the published results. Study photographs will not be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of the primary results.
Access criteria: Researchers with a methodologically sound proposal, on reasonable request to the principal investigator, under a data use agreement and in accordance with UCLA policy.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 23 months is above that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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