- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961879
Dorsal Finger Reconstruction
Comparative Study to Evaluate the Difference Between Reversed Cross Finger Flap Versus Reversed Island Homo-digital Flap in Distal Dorsal Finger Defect Reconstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt, 82525
- Sohag University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reversed Cross Finger Flap group 1
|
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 . |
Active Comparator: Reversed island Homo-digital Flap group 2
|
distal dorsal finger defect will be reconstructed by reversed island homo-digital flap - this flap is harvested from the same finger . |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference in range of motion between group 1 and group 2
Time Frame: difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-07-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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