Reconstruction of Upper Body Soft Tissue DefectsNCT07734337
Reconstruction by Thoracodorsal Artery Perforator Flap in Patients With Upper Body Soft Tissue Defects
A study testing Reconstruction in people with Reconstruction of Upper Body Soft Tissue Defects, run by Sohag University at 1 site in Egypt.
Trial summary
evaluation of versatility and reliability of thoracodorsal artery perforator flap by assessment of recipient site reach Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Reconstruction of Upper Body Soft Tissue Defects
- What is being tested?
- Reconstruction
- 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
- 3 Mar 2025to 3 Apr 2027
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 5 to 75 years old
- Both sexes
- Requiring upper body soft tissue reconstruction (e.g. breast, shoulder chest wall, axilla) following oncological resection, trauma, or contracture excision
- Adequate general condition for surgery
Who cannot join
- Patients with uncontrolled comorbidities.
- Prior surgery or radiation in the donor region that compromises vascular anatomy.
- Active local infection or poor wound bed vascularity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reconstructive Potential of The Pedicled Thoracodorsal Artery Perforator Flap; Prospective Clinical Assessment of The Arc of Rotation and Recipient-Site Reach in Upper Body Reconstruction
evaluation of versatility and reliability of thoracodorsal artery perforator flap by assessment of recipient site reach
Read the detailed description
Prospectively evaluate the reconstructive capacity of the pedicled thoracodorsal artery perforator (TDAP) flap by objectively measuring its arc of rotation and achievable recipient-site reach, and correlating these parameters with flap survival, complication rates, donor-site morbidity, and functional and aesthetic outcomes in upper body reconstruction.
- Being tested
- Reconstruction
- Keywords
- TDAP flap recipient site reach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconstructionProcedure or surgery
Harvesting thoracodorsal artery perforator flap and insetting in the recipient sites reachable for this flap
| Study group | Role | What they receive |
|---|---|---|
| Patients need reconstruction by Thoracodorsal Artery Perforator Flap | Other | Reconstruction of Upper Body by Insertion of Thoracodorsal Artery Perforator Flap to fill the Defects Receives: Procedure: Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recipient Site Reach
Measuring of Successful reach to intended recipient site without vascular compromise by centimeters from the pedicle to the recipient site
Measured: 12 months recruitment and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Mar 2025
- Primary completion3 Mar 2026
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of Upper Body Soft Tissue DefectsStudies 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
- Model description
- Patients who need reconstruction in Arm, axilla, breast and chest
- 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, Ahmed Gamal Elsayed Morsy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734337
- Sponsor's protocol ID
- Soh-Med-26-6-1MS
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Potential of The Pedicled Thoracodorsal Artery Perforator Flap; Prospective Clinical Assessment of The Arc of Rotation and Recipient-Site Reach in Upper Body Reconstruction
- ClinicalTrials.gov ID
- NCT07734337
- Acronym / sponsor ID
- Soh-Med-26-6-1MS
- Keywords
- TDAP flap recipient site reach
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 29 Jul 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.
evaluation of versatility and reliability of thoracodorsal artery perforator flap by assessment of recipient site reach
Detailed description
Prospectively evaluate the reconstructive capacity of the pedicled thoracodorsal artery perforator (TDAP) flap by objectively measuring its arc of rotation and achievable recipient-site reach, and correlating these parameters with flap survival, complication rates, donor-site morbidity, and functional and aesthetic outcomes in upper body reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who need reconstruction in Arm, axilla, breast and chest
| Arm | Type | Receives |
|---|---|---|
| Patients need reconstruction by Thoracodorsal Artery Perforator Flap | Other | Procedure: ReconstructionReconstruction of Upper Body by Insertion of Thoracodorsal Artery Perforator Flap to fill the Defects |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 5 to 75 years old
- Both sexes
- Requiring upper body soft tissue reconstruction (e.g. breast, shoulder chest wall, axilla) following oncological resection, trauma, or contracture excision
- Adequate general condition for surgery
Key exclusion criteria (3 listed)
- Patients with uncontrolled comorbidities.
- Prior surgery or radiation in the donor region that compromises vascular anatomy.
- Active local infection or poor wound bed vascularity.
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 |
|---|---|---|
| ReconstructionHarvesting thoracodorsal artery perforator flap and insetting in the recipient sites reachable for this flap | Procedure or surgery | Patients need reconstruction by Thoracodorsal Artery Perforator Flap |
Primary outcome
Recipient Site Reach
Time frame: 12 months recruitment and 6 months follow up
Measuring of Successful reach to intended recipient site without vascular compromise by centimeters from the pedicle to the recipient site
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 29 Jul 2026.
- Sui X, Qing L, Yu F, Wu P and Tang J. The versatile thoracodorsal artery perforator flap for extremity reconstruction: from simple to five types of advanced applications and clinical outcomes. J orthop surg res. 2023;18(1):973-9.Link provided by the sponsor.
- Wolff K-D and Hölzle F. Thoracodorsal Artery Perforator Flap. Raising of Microvascular Flaps: A Systematic Approach: Springer; 2025. p. 371-91.Link provided by the sponsor.
- Homsy C, Theunissen T and Sadeghi A. The Thoracodorsal Artery Perforator Flap: A Powerful Tool in Breast Reconstruction. Plast Reconstr Surg 2022;150(4):755-761.Link provided by the sponsor.
- Thomsen JB, Rindom MB, Rancati A and Angrigiani C. Thoracodorsal artery flaps for breast reconstruction-the variants and its approach. Arch Plast Surg. 2021;48(1):15-25.Link provided by the sponsor.
- Busnardo FF, Coltro PS, Olivan MV, Busnardo APV, Ferreira MC. The thoracodorsal artery perforator flap in the treatment of axillary hidradenitis suppurativa: effect on preservation of arm abduction. Plast Reconstr Surg. 2011;128(4):949-953.Link provided by the sponsor.
- 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.
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 Reconstruction in people with Reconstruction of Upper Body 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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?
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?
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?
Recipient Site Reach (time frame: 12 months recruitment and 6 months follow up). 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 29 Jul 2026.