Perforator Mapping and Optimizing Design of the Lateral Arm Flap

Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial

The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.

flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.

Study Overview

• Status: Recruiting
• Conditions: Coverage of Soft Tissue Defects
• Intervention / Treatment: Diagnostic test: coloured duplex; Procedure: supra facial dissection

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients

Exclusion Criteria:

• children injury to pedicle

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients candidate for lateral arm flap	Diagnostic test: coloured duplex; colored duplex to locate numbers sites and size of perforators.; Procedure: supra facial dissection; flap raising in supra facial plane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numbers of perforators	numbers of perforators in the flap	two years
site of perforators	distance from lateral humeral epicondyle in CM	two years
Size of perforators	size in millimeter	two years

Collaborators and Investigators

• Sponsor: Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 26, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AswanU

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