Management of Postburn Neck ContractureSCAIPNCT07865689
Pre-expanded Flap Versus Free Flap for Postburn Neck Contracture
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines in people with Management of Postburn Neck Contracture, run by South Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Management of Postburn Neck Contracture
- What is being tested?
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 13 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients were excluded if they had acute or unstable burn wounds, active infection, or severe systemic illness contraindicating surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley Department of Plastic Surgery
Qina, Qena Governorate, 83511
About this study
Official title: Pre-Expanded Supraclavicular Artery Island Flap Versus Thinned Free Flaps for Reconstruction of Grade II Postburn Neck Contracture: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Management of Postburn Neck Contracture
- Being tested
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesProcedure or surgery
Pre-expanded SCAIF and Thinned free flaps.
| Study group | Role | What they receive |
|---|---|---|
| Pre-expanded Suprascapular Artery Island flap | Active comparator | 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. Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
| Free Thinned Flap | Active comparator | Free thinned anterolateral flap and throacodorsal artery flap Receives: Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 mon
Secondary outcomes (2)
Neck function
measuring the change in CMA with a goniometer from baseline to one-year follow-up
Measured: 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
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Apr 2021
- Primary completion13 Oct 2024
- Study completion13 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Management of Postburn Neck ContractureStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim sameh Ahmed Rihan, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865689
- Sponsor's protocol ID
- SVU-MED-PIS 013-2-21-3-165
- Acronym
- SCAIP
- Status last verified
- Mar 2021
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other study investigators
Publications
https://doi.org/10.21608/svuijm.2024.339937.2031
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Expanded Supraclavicular Artery Island Flap Versus Thinned Free Flaps for Reconstruction of Grade II Postburn Neck Contracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07865689
- Acronym / sponsor ID
- SCAIP / SVU-MED-PIS 013-2-21-3-165
- Conditions
- Management of Postburn Neck Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 13 Oct 2024 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-expanded Suprascapular Artery Island flap | Active comparator | Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesThe 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. |
| Free Thinned Flap | Active comparator | Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesFree thinned anterolateral flap and throacodorsal artery flap |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients were excluded if they had acute or unstable burn wounds, active infection, or severe systemic illness contraindicating surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesPre-expanded SCAIF and Thinned free flaps. | Procedure or surgery | Free Thinned Flap, Pre-expanded Suprascapular Artery Island flap |
Primary outcome
Demographic and Surgical Parameters
Time frame: 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.
2 secondary outcomes
Neck function
Time frame: 24 month
POSAS 2
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Backgroundhttps://doi.org/10.21608/svuijm.2024.339937.2031
- Individual participant dataSharing planned: Yes. Other study investigators
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines in people with Management of Postburn Neck Contracture, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and Surgical Parameters (time frame: 24 mon). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07865689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.