Cerebral Palsy
Conditions
Keywords
Single-Event Multilevel Surgery, Wound Closure
Brief 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.
Interventions
DEVICEKnotless 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.
DEVICEConventional 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and caregiver, the research assistant who performs follow-up wound assessments, and the two independent reviewers who score coded scar photographs are masked to limb allocation. The operative note does not state which closure method was used on either limb. The statistician analyzes data with arms labeled A and B until the primary analysis is complete. The operating surgeon and the intraoperative research assistant who times closures cannot be masked.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure Time per Incision | Day of surgery (intraoperative) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection | Up to 6 months after surgery (NHSN windows of 30 and 90 days) | 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. |
| Incidence of Wound Dehiscence | Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery | 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. |
| Incidence of Suture Spitting and Other Wound Complications | Assessed at 7-10 days, 4-6 weeks, 3 months, and 6 months after surgery | 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. |
| 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) | 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. |
| Patient-Reported Scar Assessment (POSAS Patient Scale) | 3 and 6 months after surgery (6 months is the principal time point) | 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. |
| Number of Device-Related Events | From surgery through 6 months after surgery | 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. |
| Projected Closure Time Saved per Surgical Case | Day of surgery (intraoperative) | 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. |
Countries
United States
Outcome results
None listed