NCT03658603

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

August 29, 2018

Last Update Submit

September 2, 2018

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • The mean operative time

    the time from the start to the end of operation

    12 hours

Secondary Outcomes (1)

  • The percentage of patients with Flap viability

    1 week

Study Arms (2)

Study group

EXPERIMENTAL

Thoracodorsal artery perforator flap

Procedure: thoracodorsal artery perforator flap

control group

ACTIVE COMPARATOR

Conventional free flaps

Procedure: latissimus dorsi flap

Interventions

thoracodorsal artery perforator flapPROCEDURE

fascio-cutaneous flap used in cases of trauma or burns

Study group
latissimus dorsi flapPROCEDURE

musculo-cutaneous flap used in cases of trauma or burns

control group

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Soft tissue loss anywhere in the body.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

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

    PMID: 2404152BACKGROUND

  • 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.

    PMID: 15923904BACKGROUND

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

    PMID: 15779080BACKGROUND

  • 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.

    PMID: 12545116BACKGROUND

  • 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.

    PMID: 15468398BACKGROUND

  • 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.

    PMID: 17413879BACKGROUND

  • 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.

    PMID: 3737758BACKGROUND

  • 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.

    PMID: 12045540BACKGROUND

  • 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.

    PMID: 11214052BACKGROUND

  • 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.

    PMID: 17051108BACKGROUND

  • 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.

    PMID: 12560714BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Mohamed Shazly, M.D

CONTACT

01006667095elshazly@aun.edu.eg

Ahmed Tohamy, M.D

CONTACT

01002660832

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 5, 2018

Study Start

October 3, 2018

Primary Completion

August 31, 2020

Study Completion

February 28, 2021

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share