- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027542
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects
August 26, 2021 updated by: Abeer Musaddiq
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects; A CROSS-SECTIONAL STUDY OF 53 PATIENTS
Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle.
The patients' information were collected through medical records and analyzed through SPSS
Study Overview
Status
Completed
Conditions
Detailed Description
In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool .
This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status.
A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient
Study Type
Observational
Enrollment (Actual)
53
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
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75800
- Agha Khan University Hospital
-
-
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
2 months to 74 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Data of all those patients was collected who underwent reconstruction of soft tissue defects of foot and ankle with Supramalleolar and sural artery flaps between 1996 and 2020.
The data of these patients were collected from the Hospital inpatient management system and review of medical records through a structured proforma that included demographic variables, cause of soft tissue defects (secondary to open fractures, following debridement of chronic infected wounds, tumor excision and defects following release of scar contractures), side of defects, size and type of flap (supramalleolar or sural artery), complications and long-term outcome of the flap.
Description
Inclusion Criteria:
- Only defects of foot and ankle around dorsum and perimalleolar areas were included.
Exclusion Criteria:
- The defects reconstructed with other local flaps and free flaps were excluded from this review
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-designed assessment tool
Time Frame: 1996-2020
|
The functional outcome of each patient was measured by activity of daily living
|
1996-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pervaiz Hashmi, Agha Khan University Hospital
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)
November 1, 2020
Primary Completion (Actual)
January 30, 2021
Study Completion (Actual)
March 15, 2021
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 26, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 4452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
data of study participants is only accessible to researcher of this study
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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