NCT04961879

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

July 13, 2021

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

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

Study Arms (2)

Reversed Cross Finger Flap group 1

ACTIVE COMPARATOR
Procedure: Reversed Cross Finger Flap

Reversed island Homo-digital Flap group 2

ACTIVE COMPARATOR
Procedure: reversed island homo-digital flap

Interventions

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 .

Reversed Cross Finger Flap group 1

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

Reversed island Homo-digital Flap group 2

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82525, Egypt

Location

MeSH Terms

Conditions

Finger Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 14, 2021

Study Start

July 14, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations