Reconstruction of Hand Soft Tissue Defects

NCT05218252 | Unknown

• 1 other identifier: Soh-Med-22-01-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Injuries

Keywords

Posterior interosseous artery flap; Hand soft tissue defects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hand soft tissue defects

OTHER

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

Interventions

Posterior interosseous artery flap PROCEDURE

The use of distally based posterior interosseous artery flap from the forearm in reconstructing mild to moderate hand soft tissue defects

Hand soft tissue defects

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Availability of a healthy donor site.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ahmed Talaat

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Talaat, Demonstrator

CONTACT

+2001013610088; drahmed202022@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 1, 2022
• Study Start: January 6, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)