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Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658603
Recruitment Status : Unknown
Verified September 2018 by Sara Diefy Salem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Diefy Salem, Assiut University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Trauma Procedure: thoracodorsal artery perforator flap Procedure: latissimus dorsi flap Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction
Estimated Study Start Date : October 3, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Thoracodorsal artery perforator flap
 Procedure: thoracodorsal artery perforator flap
fascio-cutaneous flap used in cases of trauma or burns
Active Comparator: control group
Conventional free flaps
 Procedure: latissimus dorsi flap
musculo-cutaneous flap used in cases of trauma or burns


Outcome Measures
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Primary Outcome Measures :
  1. The mean operative time [ Time Frame: 12 hours ]
    the time from the start to the end of operation


Secondary Outcome Measures :
  1. The percentage of patients with Flap viability [ Time Frame: 1 week ]
    The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering)


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Soft tissue loss anywhere in the body.

Exclusion Criteria:

• Patients with chronic debilitating diseases e.g. chronic renal failure, uncontrolled diabetes mellitus

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658603


Contacts
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Contact: Mohamed Shazly, M.D 01006667095 ext 002 elshazly@aun.edu.eg
Contact: Ahmed Tohamy, M.D 01002660832 ext 002

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Sara Diefy Salem, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03658603    
Other Study ID Numbers: TAPF
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No