Management of Postburn Neck Contracture
Conditions
Brief summary
This prospective, randomized, parallel-group trial was conducted at two tertiary care centers in Egypt between April 2022 and October 2024. The study was approved by the local Research Ethics Committee and conducted in accordance with the principles of the Declaration of Helsinki. The trial was conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Detailed description
Thirty-four patients were assessed for eligibility; eight were excluded, leaving 26 patients randomized equally to pre-expanded SCAIF (n = 13) or thinned free-flap reconstruction (n = 13). In Group A, one patient developed expander extrusion, and another was lost to follow-up after flap surgery, leaving 11 patients for analysis. All 13 patients in Group B completed follow-up. Thus, 24 patients were included in the final analysis. Written informed consent was obtained from all participants or, for those younger than 18 years, from a parent or legal guardian, with assent obtained where appropriate.
Interventions
Pre-expanded SCAIF and Thinned free flaps.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients were eligible for inclusion if they were older than 5 years, had a postburn neck contracture classified as grade II (subtype IIa or IIb) according to the Gao6 classification, were considered suitable for reconstructive surgery and fit to undergo general anesthesia, and were willing to participate and complete the scheduled follow-up.
Exclusion criteria
* Patients were excluded if they had acute or unstable burn wounds, active infection, or severe systemic illness contraindicating surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic and Surgical Parameters | 24 mon | Preoperative assessment included demographic and burn-related characteristics, contracture type and location, previous reconstructive procedures, and donor-site suitability. Intraoperative variables included flap type and dimensions, defect and flap surface areas, flap thickness before and after thinning, and method of donor-site closure. Flap survival, recipient- and donor-site complications, donor-site morbidity, and secondary procedures, including Z-plasty, scar revision, flap debulking or liposuction, and further contracture release, were recorded throughout follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck function | 24 month | measuring the change in CMA with a goniometer from baseline to one-year follow-up |
| POSAS 2 | 24 month | Scar quality was evaluated at the same time points using POSAS 2. The observer component assessed vascularity, pigmentation, thickness, relief, pliability, surface area, and overall opinion, while the patient component assessed pain, itching, color, stiffness, thickness, irregularity, and overall opinion. Each item was scored from 1 (normal skin) to 10 (worst imaginable scar), and total observer and patient scores were calculated separately. The validated Arabic version of POSAS 2 was used for patient-reported assessment |
Countries
Egypt
Outcome results
None listed