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NCT03658603 Clinical Trial

Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps

Trauma Clinical Trial

Official title:
Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03658603
Other study ID # TAPF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 3, 2018
Est. completion date February 28, 2021

Study information
Verified date September 2018
Source Assiut University
Contact Mohamed Shazly, M.D
Phone 01006667095
Email elshazly@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date February 28, 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 60 Years
Eligibility Inclusion Criteria:

• Soft tissue loss anywhere in the body.

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• thoracodorsal artery perforator flap
fascio-cutaneous flap used in cases of trauma or burns
• latissimus dorsi flap
musculo-cutaneous flap used in cases of trauma or burns

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (11)

Cannon B. The flowering of plastic surgery. JAMA. 1990 Feb 9;263(6):862-4. — View Citation

Geddes CR, Morris SF, Neligan PC. Perforator flaps: evolution, classification, and applications. Ann Plast Surg. 2003 Jan;50(1):90-9. Review. — View Citation

Hallock GG. Direct and indirect perforator flaps: the history and the controversy. Plast Reconstr Surg. 2003 Feb;111(2):855-65; quiz 866. — View Citation

Hwang 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. — View Citation

Kim JT, Koo BS, Kim SK. The thin latissimus dorsi perforator-based free flap for resurfacing. Plast Reconstr Surg. 2001 Feb;107(2):374-82. — View Citation

Lin 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):1376-86; discussion 1387. — View Citation

Lineaweaver WC. Microsurgery and the reconstructive ladder. Microsurgery. 2005;25(3):185-6. — View Citation

Mardini S, Wei FC, Salgado CJ, Chen HC. Reconstruction of the reconstructive ladder. Plast Reconstr Surg. 2005 Jun;115(7):2174. — View Citation

Russell 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. — View Citation

Wei 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. — View Citation

Wei FC, Mardini S. Free-style free flaps. Plast Reconstr Surg. 2004 Sep 15;114(4):910-6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary The mean operative time the time from the start to the end of operation 12 hours
Secondary The percentage of patients with Flap viability The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering) 1 week
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