Reconstruction of Hand Soft Tissue Defects

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218252
• Other study ID #: Soh-Med-22-01-06
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: Ahmed Talaat, Demonstrator
• Phone: +2001013610088
• Email: drahmed202022[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 identi?ed 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