Reconstruction of Hand Soft Tissue Defects

Reliability and Versatility of Posterior Interosseous Artery Flap in Reconstructing Hand Soft Tissue Defects.

Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.

Study Overview

• Status: Recruiting
• Conditions: Hand Injuries
• Intervention / Treatment: Procedure: Posterior interosseous artery flap

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Talaat, Demonstrator; Phone Number: +2001013610088; Email: drahmed202022@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag university Hospital
    • Contact: Ahmed Talaat, Demonstrator; Phone Number: +2001013610088; Email: drahmed202022@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space.
2. Small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity.
3. Availability of a healthy donor site.

Exclusion Criteria:

1. Patients with a major uncontrollable medical illness.
2. Chronic heavy smokers.
3. Traumatic injury to the donor site.
4. Complex defects of the hand beyond the PIP joint level.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hand soft tissue defects; Patients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities.	Procedure: Posterior interosseous artery flap; The use of distally based posterior interosseous artery flap from the forearm in reconstructing mild to moderate hand soft tissue defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional and aesthetic outcomes of posterior interosseous artery flap	All patients will be evaluated with objective (functional) and subjective (aesthetic) criteria. Hand functionality will be evaluated using the disability of the arm, shoulder, and hand (DASH) score. The DASH score comprises 30 questions, and the score ranges from 30 points, for no limitation, to 150 points, for maximum limitation. The outcomes will be aesthetically reviewed with scar assessment measured as being good, fair, and poor. This assessment is subjective. Donor site problems are identified as cold intolerance, numbness, and pain. These will be evaluated as being either present in the patient or non-existent.	5 months from the end of treatment

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Ahmed Talaat, Sohag university Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Posterior interosseous artery flap; Hand soft tissue defects
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: Soh-Med-22-01-06

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