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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
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
January 17, 2022
Last Updated
June 29, 2022
Sponsor
Sohag University
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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.
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
No
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
Email
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
Email
drahmed202022@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Reconstruction of Hand Soft Tissue Defects

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