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Reconstruction of Hand Soft Tissue Defects

Primary Purpose

Hand Injuries

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Posterior interosseous artery flap

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring Posterior interosseous artery flap, Hand soft tissue defects

Eligibility Criteria

3 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hand soft tissue defects

Arm Description

Patients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05218252

First Posted

January 17, 2022

Last Updated

June 29, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05218252

Brief Title

Reconstruction of Hand Soft Tissue Defects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2022 (Actual)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Injuries

Keywords

Posterior interosseous artery flap, Hand soft tissue defects

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hand soft tissue defects

Arm Type

Other

Arm Description

Patients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities.

Intervention Type

Procedure

Intervention Name(s)

Posterior interosseous artery flap

Intervention Description

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

Primary Outcome Measure Information:

Title

Functional and aesthetic outcomes of posterior interosseous artery flap

Description

Time Frame

5 months from the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Talaat, Demonstrator

Phone

+2001013610088

drahmed202022@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Talaat

Organizational Affiliation

Sohag University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Talaat, Demonstrator

Phone

+2001013610088

drahmed202022@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Reconstruction of Hand Soft Tissue Defects

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