Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh FlapNCT06841419
Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects
A study testing surgical reconstruction of a soft tissue defects by a pedicled flap in people with Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap and Post Tumor Excision Soft Tissue Defects, run by Sohag University at 1 site in Egypt.
Trial summary
a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap, Post Tumor Excision Soft Tissue Defects, Post Debridement Soft Tissue Defects
- What is being tested?
- surgical reconstruction of a soft tissue defects by a pedicled flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with clean hip, thighs or lower abdomen defects either traumatic or non_traumatic that cannot be closed primarily.
Who cannot join
- Patients with possible compromise of vascular pedicle due to previous trauma or surgery.
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospitals
Sohag, 82511
Abdelnaser Mohamed Ahmed, resident in plastic surgery, +20 1550435303, dr.nasser5656@gmail.com
About this study
a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome.
- Conditions
- Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap, Post Tumor Excision Soft Tissue Defects, Post Debridement Soft Tissue Defects
- Being tested
- surgical reconstruction of a soft tissue defects by a pedicled flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical reconstruction of a soft tissue defects by a pedicled flapProcedure or surgery
harvesting of a fasciocutaneous flap from the anterolateral aspect of thigh based on a perforators from the descending branch of lateral femoral circumflex artery to reconstruct a neighboring soft tissue defect.
| Study group | Role | What they receive |
|---|---|---|
| a group of patients with hip, thighs, knees and lower abdomen regions soft tissue defects | Experimental | treating patients of the group mentioned by reconstructing their tissue defects by pedicled anterolateral thigh flap. Receives: Procedure: surgical reconstruction of a soft tissue defects by a pedicled flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap Survival Rate
The percentage of flaps that survive completely without necrosis or partial loss. Complications will be graded (e.g., total flap loss, partial necrosis, or marginal necrosis).
Unit: Percentage. Measurement Tool: ruler/(Mesure).
Measured: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes (2)
Range of Motion in Reconstructed Area
Assessment of the range of motion in the reconstructed area. Unit: Degrees. Measurement Tool: Goniometer.
Measured: "From enrollment to the end of treatment at 8 weeks"
Strength in Reconstructed Area
Evaluation of muscle strength in the reconstructed area. Unit: Newton (N). Measurement Tool: Dynamometer.
Measured: "From enrollment to the end of treatment at 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start15 Feb 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh FlapStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelnasser Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841419
- Sponsor's protocol ID
- Soh-Med--12-1-03MS
- Status last verified
- May 2025
- First submitted
- 24 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects
- ClinicalTrials.gov ID
- NCT06841419
- Acronym / sponsor ID
- Soh-Med--12-1-03MS
- Conditions
- Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap, Post Tumor Excision Soft Tissue Defects, Post Debridement Soft Tissue Defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Feb 2025 (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.
a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a group of patients with hip, thighs, knees and lower abdomen regions soft tissue defects | Experimental | Procedure: surgical reconstruction of a soft tissue defects by a pedicled flaptreating patients of the group mentioned by reconstructing their tissue defects by pedicled anterolateral thigh flap. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with clean hip, thighs or lower abdomen defects either traumatic or non_traumatic that cannot be closed primarily.
Key exclusion criteria (2 listed)
- Patients with possible compromise of vascular pedicle due to previous trauma or surgery.
- Patient refusal
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 |
|---|---|---|
| surgical reconstruction of a soft tissue defects by a pedicled flapharvesting of a fasciocutaneous flap from the anterolateral aspect of thigh based on a perforators from the descending branch of lateral femoral circumflex artery to reconstruct a neighboring soft tissue defect. | Procedure or surgery | a group of patients with hip, thighs, knees and lower abdomen regions soft tissue defects |
Primary outcome
Flap Survival Rate
Time frame: "From enrollment to the end of treatment at 8 weeks"
The percentage of flaps that survive completely without necrosis or partial loss. Complications will be graded (e.g., total flap loss, partial necrosis, or marginal necrosis). Unit: Percentage. Measurement Tool: ruler/(Mesure).
2 secondary outcomes
Range of Motion in Reconstructed Area
Time frame: "From enrollment to the end of treatment at 8 weeks"
Strength in Reconstructed Area
Time frame: "From enrollment to the end of treatment at 8 weeks"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical reconstruction of a soft tissue defects by a pedicled flap in people with Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap and Post Tumor Excision Soft Tissue Defects, run by Sohag 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 2 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelnaser Mohamed Ahmed, resident in Plastic surgery (+20 01550435303, dr.nasser5656@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap Survival Rate (time frame: "From enrollment to the end of treatment at 8 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.