An interventional study of surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines in Management of Postburn Neck Contracture, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by South Valley University · Not applicable, Interventional, and Treatment
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.
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.
South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
The supraclavicular artery was mapped preoperatively using a hand-held Doppler within the anatomical triangle bounded inferiorly by the clavicle, medially by the posterior border of the sternocleidomastoid muscle (SCM), and laterally by the external jugular vein (EJV). Under general anesthesia, patients were positioned in approximately a 45° lateral tilt with moderate neck extension. The incision and expander pocket were infiltrated with 1% lidocaine with adrenaline (1:20,000). In nine patients, the expander was placed distally through a small transverse pectoral incision, whereas in two patients it was positioned centrally through a posterior incision over the trapezius muscle. In the latter, the SCA was identified and marked by wrapping a separate short segment of the expander connecting silicone tube around the vessel, facilitating its identification during the second stage. The expander was partially filled with saline to obliterate dead space.
Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Free thinned anterolateral flap and throacodorsal artery flap
Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Pre-expanded SCAIF and Thinned free flaps.
Demographic and Surgical Parameters
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.
Time frame: 24 mon
Neck function
measuring the change in CMA with a goniometer from baseline to one-year follow-up
Time frame: 24 month
POSAS 2
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
Time frame: 24 month
Plan to share: Yes — Other study investigators
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 3 years
Access criteria: the study investiagtors
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 completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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