- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319586
The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries
March 19, 2024 updated by: Mahmoud Abdelmawla Mohamed, Sohag University
The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin.
It's used in reconstruction of the mutilated hand as a reverse pedicled flap.
The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein.
Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves.
The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts.
Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- patients aging 5 to 80 years.
- Soft Tissue defects following MCA injuries.
- Defect size less than 30 cm
Exclusion Criteria:
- Peripheral vascular disease
- Underling bone osteomyelitis
- Unhealthy skin of volatile aspect of donor forearm
- Defect more than 30 cm
- Ulnar artery previous ligated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Viability of the flap
Time Frame: 12 months
|
viability of the flap including color, warmth, capillary refill, smell and turgor
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noaman HH. Management of upper limb bone defects using free vascularized osteoseptocutaneous fibular bone graft. Ann Plast Surg. 2013 Nov;71(5):503-9. doi: 10.1097/SAP.0b013e3182a1aff0.
- Noaman HH, Shiha AE. Repeated upper limb salvage in a case of severe traumatic soft-tissue and brachial artery defect. Microsurgery. 2002;22(6):249-53. doi: 10.1002/micr.10045.
- Noaman HH. Salvage of complete degloved digits with reversed vascularized pedicled forearm flap: a new technique. J Hand Surg Am. 2012 Apr;37(4):832-6. doi: 10.1016/j.jhsa.2012.01.032. Epub 2012 Mar 6.
- Kaufman MR, Jones NF. The reverse radial forearm flap for soft tissue reconstruction of the wrist and hand. Tech Hand Up Extrem Surg. 2005 Mar;9(1):47-51. doi: 10.1097/01.bth.0000154479.20226.22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2024
Primary Completion (Actual)
February 7, 2024
Study Completion (Actual)
February 7, 2024
Study Registration Dates
First Submitted
March 10, 2024
First Submitted That Met QC Criteria
March 19, 2024
First Posted (Actual)
March 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-02-08MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.