Reconstruction of Hand Soft Tissue Defects

Not Applicable

• Conditions: Hand Injuries
• Interventions: Procedure: Posterior interosseous artery flap

• Registration Number: NCT05218252
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-29
• Study First Posted: 2022-02-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Primary Completion: 2022-07
• Last Update Posted: 2022-07-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand soft tissue defects	Posterior interosseous artery flap	Patients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities.

Primary Outcome Measures

Name	Time	Method
Functional and aesthetic outcomes of posterior interosseous artery flap	5 months from the end of treatment	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.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt