Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects

May 12, 2025 updated by: Abdelnasser Mohamed Ahmed, Sohag University
a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdelnaser Mohamed Ahmed, resident in Plastic surgery
  • Phone Number: +20 01550435303
  • Email: dr.nasser5656@gmail.com

Study Locations

  • Egypt
      • Sohag, Egypt, 82511
        • Recruiting
        • Sohag University hospitals
        • Contact:
          • Abdelnaser Mohamed Ahmed, resident in plastic surgery
          • Phone Number: +20 1550435303
          • Email: dr.nasser5656@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients with clean hip, thighs or lower abdomen defects either traumatic or non_traumatic that cannot be closed primarily.

Exclusion Criteria:

  • Patients with possible compromise of vascular pedicle due to previous trauma or surgery.
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a group of patients with hip, thighs, knees and lower abdomen regions soft tissue defects
treating patients of the group mentioned by reconstructing their tissue defects by pedicled anterolateral thigh flap.
Procedure: surgical reconstruction of a soft tissue defects by a pedicled flap
harvesting of a fasciocutaneous flap from the anterolateral aspect of thigh based on a perforators from the descending branch of lateral femoral circumflex artery to reconstruct a neighboring soft tissue defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flap Survival Rate
Time Frame: "From enrollment to the end of treatment at 8 weeks"

The percentage of flaps that survive completely without necrosis or partial loss. Complications will be graded (e.g., total flap loss, partial necrosis, or marginal necrosis).

Unit: Percentage. Measurement Tool: ruler/(Mesure).
"From enrollment to the end of treatment at 8 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion in Reconstructed Area
Time Frame: "From enrollment to the end of treatment at 8 weeks"
Assessment of the range of motion in the reconstructed area. Unit: Degrees. Measurement Tool: Goniometer.
"From enrollment to the end of treatment at 8 weeks"
Strength in Reconstructed Area
Time Frame: "From enrollment to the end of treatment at 8 weeks"
Evaluation of muscle strength in the reconstructed area. Unit: Newton (N). Measurement Tool: Dynamometer.
"From enrollment to the end of treatment at 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med--12-1-03MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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