Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction

May 20, 2017 updated by: alhussein Ahmed Mahmoud El-Dahshan
the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Locations

  • Egypt
    • Assiut
      • Assuit, Assiut, Egypt, 7771
        • Assiut University

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

any individual having post traumatic soft tissue defect of plantar surface requiring free flap reconstruction regardless to age

Description

Inclusion Criteria:

  1. Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage
  2. At any age

Exclusion Criteria:

1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
free skin flaps
Procedure: plantar surface reconstruction by free flaps
use of free skin or free muscle flaps for reconstruction of plantar surface
free muscle flaps
Procedure: plantar surface reconstruction by free flaps
use of free skin or free muscle flaps for reconstruction of plantar surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to mobilize
Time Frame: 2 years
2 years
Requirement of specialized Footwear
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
flap ulceration
Time Frame: 2 years
2 years
Shear forces across the flap
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

alhussein Ahmed Mahmoud El-Dahshan

Investigators

  • Study Director: Amr El-Said Ali Ibrahim, MD, Assiut 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)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

May 12, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 20, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • salmaalhussein

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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