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Dorsal Finger Reconstruction

Primary Purpose

Finger Injuries

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Reversed Cross Finger Flap

reversed island homo-digital flap

About this trial

This is an interventional treatment trial for Finger Injuries

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with dorsal digital defect distal to distal interphalangeal joint (DIP) joint
defect size ranged from 1 to 2 cm in width and 1-3 cm in length

Exclusion Criteria:

chronic heavy smokers,
traumatic injury to the donor site and perforator .

Sites / Locations

Sohag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Reversed Cross Finger Flap group 1

Reversed island Homo-digital Flap group 2

Arm Description

Outcomes

Primary Outcome Measures

difference in range of motion between group 1 and group 2

difference in range of motion between group 1 and group 2 will be measured by manual goniometer in degrees

Secondary Outcome Measures

Full Information

NCT ID

NCT04961879

First Posted

July 13, 2021

Last Updated

February 16, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04961879

Brief Title

Dorsal Finger Reconstruction

Official Title

Comparative Study to Evaluate the Difference Between Reversed Cross Finger Flap Versus Reversed Island Homo-digital Flap in Distal Dorsal Finger Defect Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 14, 2021 (Actual)

Primary Completion Date

February 2022 (Anticipated)

Study Completion Date

March 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

objective of this study is To compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability & functional and aesthetic outcomes . comparative study that will be conducted at Plastic surgery department, Sohag university hospital on 30 patients .The population of the study will be patients with distal dorsal digital defects. We will divide the cases into two equal groups: the first are operated with reversed cross-finger flap and the second are operated with reversed island homo-digital flap.

6. Conditions and Keywords

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

Finger Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reversed Cross Finger Flap group 1

Arm Type

Active Comparator

Arm Title

Reversed island Homo-digital Flap group 2

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Reversed Cross Finger Flap

Intervention Description

distal dorsal finger defect will be reconstructed by reversed cross finger flap - reversed cross finger flap is a modified cross finger flap harvested from an adjacent finger .

Intervention Type

Procedure

Intervention Name(s)

reversed island homo-digital flap

Intervention Description

distal dorsal finger defect will be reconstructed by reversed island homo-digital flap - this flap is harvested from the same finger .

Primary Outcome Measure Information:

Title

difference in range of motion between group 1 and group 2

Description

difference in range of motion between group 1 and group 2 will be measured by manual goniometer in degrees

Time Frame

difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with dorsal digital defect distal to distal interphalangeal joint (DIP) joint defect size ranged from 1 to 2 cm in width and 1-3 cm in length Exclusion Criteria: chronic heavy smokers, traumatic injury to the donor site and perforator .

Facility Information:

Facility Name

Sohag University

City

Sohag

ZIP/Postal Code

82525

Country

Egypt

12. IPD Sharing Statement

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Dorsal Finger Reconstruction

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