Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps

NCT ID: NCT03658603

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Thoracodorsal artery perforator flap

Group Type EXPERIMENTAL

thoracodorsal artery perforator flap

Intervention Type PROCEDURE

fascio-cutaneous flap used in cases of trauma or burns

control group

Conventional free flaps

Group Type ACTIVE_COMPARATOR

latissimus dorsi flap

Intervention Type PROCEDURE

musculo-cutaneous flap used in cases of trauma or burns

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

thoracodorsal artery perforator flap

fascio-cutaneous flap used in cases of trauma or burns

Intervention Type PROCEDURE

latissimus dorsi flap

musculo-cutaneous flap used in cases of trauma or burns

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Soft tissue loss anywhere in the body.

Exclusion Criteria

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

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara Diefy Salem

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Shazly, M.D

Role: CONTACT

01006667095 ext. 002

Ahmed Tohamy, M.D

Role: CONTACT

01002660832 ext. 002

References

Explore related publications, articles, or registry entries linked to this study.

Cannon B. The flowering of plastic surgery. JAMA. 1990 Feb 9;263(6):862-4. No abstract available.

Reference Type BACKGROUND
PMID: 2404152 (View on PubMed)

Mardini 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.

Reference Type BACKGROUND
PMID: 15923904 (View on PubMed)

Lineaweaver WC. Microsurgery and the reconstructive ladder. Microsurgery. 2005;25(3):185-6. doi: 10.1002/micr.20125. No abstract available.

Reference Type BACKGROUND
PMID: 15779080 (View on PubMed)

Geddes 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.

Reference Type BACKGROUND
PMID: 12545116 (View on PubMed)

Wei 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.

Reference Type BACKGROUND
PMID: 15468398 (View on PubMed)

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. doi: 10.1097/01.sap.0000243998.35882.7d.

Reference Type BACKGROUND
PMID: 17413879 (View on PubMed)

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. doi: 10.1097/00006534-198609000-00009.

Reference Type BACKGROUND
PMID: 3737758 (View on PubMed)

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. doi: 10.1097/00006534-200206000-00007.

Reference Type BACKGROUND
PMID: 12045540 (View on PubMed)

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. doi: 10.1097/00006534-200102000-00012.

Reference Type BACKGROUND
PMID: 11214052 (View on PubMed)

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):1376-1386. doi: 10.1097/01.prs.0000239525.44657.81.

Reference Type BACKGROUND
PMID: 17051108 (View on PubMed)

Hallock 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.

Reference Type BACKGROUND
PMID: 12560714 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAPF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nipple Neurotization
NCT05897463 COMPLETED