TraumaNCT03658603
Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps
A study testing thoracodorsal artery perforator flap and latissimus dorsi flap in people with Trauma, run by Assiut University.
Trial summary
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- thoracodorsal artery perforator flap and latissimus dorsi flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2018to 28 Feb 2021
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Soft tissue loss anywhere in the body.
Who cannot join
- Patients with chronic debilitating diseases e.g. chronic renal failure, uncontrolled diabetes mellitus
Trial locations and contacts
No sites are listed yet.
Ahmed Tohamy, M.D contact
About this study
Official title: Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.
Read the detailed description
The field of plastic surgery, unlike most other surgical specialties, has no anatomic or functional area to which it can lay claim; the plastic surgeon practices methods and techniques applicable to all specialties and anatomic areas.
Reconstructive surgery is the process of restoring the human body to "whole" following tumor extirpation, infection, trauma or congenital or acquired deformity - restoring both form and function.
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.
- Conditions
- Trauma
- Being tested
- thoracodorsal artery perforator flap, latissimus dorsi flap
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracodorsal artery perforator flapProcedure or surgery
fascio-cutaneous flap used in cases of trauma or burns
latissimus dorsi flapProcedure or surgery
musculo-cutaneous flap used in cases of trauma or burns
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Thoracodorsal artery perforator flap Receives: Procedure: thoracodorsal artery perforator flap |
| control group | Active comparator | Conventional free flaps Receives: Procedure: latissimus dorsi flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean operative time
the time from the start to the end of operation
Measured: 12 hours
Secondary outcomes (1)
The percentage of patients with Flap viability
The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Oct 2018 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Diefy Salem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658603
- Sponsor's protocol ID
- TAPF
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cannon B. The flowering of plastic surgery. JAMA. 1990 Feb 9;263(6):862-4. No abstract available.
PubMed 2404152Mardini S, Wei FC, Salgado CJ, Chen HC. Reconstruction of the reconstructive ladder. Plast Reconstr Surg. 2005 Jun;115(7):2174. doi: 10.1097/01.prs.0000165497.92397.be. No abstract available.
PubMed 15923904Lineaweaver WC. Microsurgery and the reconstructive ladder. Microsurgery. 2005;25(3):185-6. doi: 10.1002/micr.20125. No abstract available.
PubMed 15779080Geddes CR, Morris SF, Neligan PC. Perforator flaps: evolution, classification, and applications. Ann Plast Surg. 2003 Jan;50(1):90-9. doi: 10.1097/00000637-200301000-00016.
PubMed 12545116Wei FC, Mardini S. Free-style free flaps. Plast Reconstr Surg. 2004 Sep 15;114(4):910-6. doi: 10.1097/01.prs.0000133171.65075.81.
PubMed 15468398Hwang JH, Kim ES, Kim KS, Kim DY, Lee SY. Latissimus dorsi muscle and its short perforator-based skin compound free flap. Ann Plast Surg. 2007 Apr;58(4):381-7. doi: 10.1097/01.sap.0000243998.35882.7d.
PubMed 17413879Russell RC, Pribaz J, Zook EG, Leighton WD, Eriksson E, Smith CJ. Functional evaluation of latissimus dorsi donor site. Plast Reconstr Surg. 1986 Sep;78(3):336-44. doi: 10.1097/00006534-198609000-00009.
PubMed 3737758Wei FC, Jain V, Celik N, Chen HC, Chuang DC, Lin CH. Have we found an ideal soft-tissue flap? An experience with 672 anterolateral thigh flaps. Plast Reconstr Surg. 2002 Jun;109(7):2219-26; discussion 2227-30. doi: 10.1097/00006534-200206000-00007.
PubMed 12045540Kim JT, Koo BS, Kim SK. The thin latissimus dorsi perforator-based free flap for resurfacing. Plast Reconstr Surg. 2001 Feb;107(2):374-82. doi: 10.1097/00006534-200102000-00012.
PubMed 11214052Lin CT, Huang JS, Yang KC, Hsu KC, Chen JS, Chen LW. Reliability of anatomical landmarks for skin perforators of the thoracodorsal artery perforator flap. Plast Reconstr Surg. 2006 Nov;118(6):1376-1386. doi: 10.1097/01.prs.0000239525.44657.81.
PubMed 17051108Hallock GG. Direct and indirect perforator flaps: the history and the controversy. Plast Reconstr Surg. 2003 Feb;111(2):855-65; quiz 866. doi: 10.1097/01.PRS.0000040462.38363.C7.
PubMed 12560714
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction
- ClinicalTrials.gov ID
- NCT03658603
- Acronym / sponsor ID
- TAPF
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Oct 2018 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 5 Sep 2018 (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.
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.
Detailed description
The field of plastic surgery, unlike most other surgical specialties, has no anatomic or functional area to which it can lay claim; the plastic surgeon practices methods and techniques applicable to all specialties and anatomic areas.
Reconstructive surgery is the process of restoring the human body to "whole" following tumor extirpation, infection, trauma or congenital or acquired deformity - restoring both form and function.
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: thoracodorsal artery perforator flapThoracodorsal artery perforator flap |
| control group | Active comparator | Procedure: latissimus dorsi flapConventional free flaps |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Soft tissue loss anywhere in the body.
Key exclusion criteria (1 listed)
- Patients with chronic debilitating diseases e.g. chronic renal failure, uncontrolled diabetes mellitus
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 |
|---|---|---|
| thoracodorsal artery perforator flapfascio-cutaneous flap used in cases of trauma or burns | Procedure or surgery | Study group |
| latissimus dorsi flapmusculo-cutaneous flap used in cases of trauma or burns | Procedure or surgery | control group |
Primary outcome
The mean operative time
Time frame: 12 hours
the time from the start to the end of operation
1 secondary outcome
The percentage of patients with Flap viability
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 2404152Cannon B. The flowering of plastic surgery. JAMA. 1990 Feb 9;263(6):862-4. No abstract available.
- Background: PubMed 15923904Mardini S, Wei FC, Salgado CJ, Chen HC. Reconstruction of the reconstructive ladder. Plast Reconstr Surg. 2005 Jun;115(7):2174. doi: 10.1097/01.prs.0000165497.92397.be. No abstract available.
- Background: PubMed 15779080Lineaweaver WC. Microsurgery and the reconstructive ladder. Microsurgery. 2005;25(3):185-6. doi: 10.1002/micr.20125. No abstract available.
- Background: PubMed 12545116Geddes CR, Morris SF, Neligan PC. Perforator flaps: evolution, classification, and applications. Ann Plast Surg. 2003 Jan;50(1):90-9. doi: 10.1097/00000637-200301000-00016.
- Background: PubMed 15468398Wei FC, Mardini S. Free-style free flaps. Plast Reconstr Surg. 2004 Sep 15;114(4):910-6. doi: 10.1097/01.prs.0000133171.65075.81.
- Background: PubMed 17413879Hwang JH, Kim ES, Kim KS, Kim DY, Lee SY. Latissimus dorsi muscle and its short perforator-based skin compound free flap. Ann Plast Surg. 2007 Apr;58(4):381-7. doi: 10.1097/01.sap.0000243998.35882.7d.
- Background: PubMed 3737758Russell RC, Pribaz J, Zook EG, Leighton WD, Eriksson E, Smith CJ. Functional evaluation of latissimus dorsi donor site. Plast Reconstr Surg. 1986 Sep;78(3):336-44. doi: 10.1097/00006534-198609000-00009.
- Background: PubMed 12045540Wei FC, Jain V, Celik N, Chen HC, Chuang DC, Lin CH. Have we found an ideal soft-tissue flap? An experience with 672 anterolateral thigh flaps. Plast Reconstr Surg. 2002 Jun;109(7):2219-26; discussion 2227-30. doi: 10.1097/00006534-200206000-00007.
- Background: PubMed 11214052Kim JT, Koo BS, Kim SK. The thin latissimus dorsi perforator-based free flap for resurfacing. Plast Reconstr Surg. 2001 Feb;107(2):374-82. doi: 10.1097/00006534-200102000-00012.
- Background: PubMed 17051108Lin CT, Huang JS, Yang KC, Hsu KC, Chen JS, Chen LW. Reliability of anatomical landmarks for skin perforators of the thoracodorsal artery perforator flap. Plast Reconstr Surg. 2006 Nov;118(6):1376-1386. doi: 10.1097/01.prs.0000239525.44657.81.
- Background: PubMed 12560714Hallock GG. Direct and indirect perforator flaps: the history and the controversy. Plast Reconstr Surg. 2003 Feb;111(2):855-65; quiz 866. doi: 10.1097/01.PRS.0000040462.38363.C7.
- Individual participant dataSharing planned: No
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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.
Ahmed Tohamy, M.D contact
Questions about this trial
What is this clinical trial studying?
A study testing thoracodorsal artery perforator flap and latissimus dorsi flap in people with Trauma, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shazly, M.D (01006667095 ext. 002, elshazly@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean operative time (time frame: 12 hours). 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 NCT03658603, which also lists 11 linked publications.
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 5 Sep 2018.