Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects

This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts

Study Overview

• Status: Recruiting
• Conditions: Reconstruction of Head Soft Tissue Defects; Reconstruction of Neck Soft Tissue Defects
• Intervention / Treatment: Procedure: Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmad A Albadry; Phone Number: 20111088856; Email: ahmedahmed@med.sohag.edu.eg
• Study Contact Backup: Name: Karam A Mohammed; Phone Number: 201021777543; Email: Karam.allam@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag Faculty of Medicine
    • Contact: Karam A Mohammed; Phone Number: 201021777543; Email: Karam.allam@med.sohag.edu.eg
    • Contact: Ahmad A Albadry; Phone Number: 201110884856; Email: ahmedahmed@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with head and neck soft tissue defect either traumatic or non-traumatic
• Available healthy donor site

Exclusion Criteria:

• Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.
• Patients with a major uncontrollable medical illness, chronic heavy smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patient operated by Supraclavicular Artery flap for Reconstruction; Supraclavicular artery flap will be used for reconstruction

Procedure: Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap; Supraclavicular artery flap will be used in the reconstruction of traumatic and non-traumatic defects of head and neck.Flap harvesting and reconstruction will be performed under general anesthesia. The defect dimensions are measured and the superficial landmarks for the supraclavicular artery are drawn .The flap will be used as island flap, transposed or interpolated flap depending on the arc of rotation needed to achieve flap inset without tension and flap elevation proceeds from lateral to medial.The flap is rotated and inset into the defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap Success	The flap success will be measured by percentage of patients in which there is flap survival versus percentage of patient with flap necrosis	6 month post-surgery
Flap complications	assessment of flap complication will be assessed by percentage of patients in which there is flap dehiscence , flap infection and flap necrosis	6 months post-surgery
patients satisfaction as regard flap color match	patient satisfaction as will be assessed with questionnaire	6 months post-surgery
patients satisfaction as regard flap texture match	patient satisfaction as will be assessed with questionnaire	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible flap lengths	The achieved flap length will be measured in centimeters	6 months post-surgery
Possible flap widths	The achieved flap width will be measured in centimeters	6 months post-surgery

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Ahmad A Albadry, Sohag University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-23-01-03

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