for Upper Limb Soft Tissue CoverageNCT06319586
The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries
A study testing Radial Forearm Flap in people with for Upper Limb Soft Tissue Coverage, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- for Upper Limb Soft Tissue Coverage
- What is being tested?
- Radial Forearm Flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2024to 7 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients aging 5 to 80 years.
- Soft Tissue defects following MCA injuries.
- Defect size less than 30 cm
Who cannot join
- Peripheral vascular disease
- Underling bone osteomyelitis
- Unhealthy skin of volatile aspect of donor forearm
- Defect more than 30 cm
- Ulnar artery previous ligated
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- for Upper Limb Soft Tissue Coverage
- Being tested
- Radial Forearm Flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Forearm FlapProcedure or surgery
- Elevate the flap from ulnar to radial side toward the FCR
- Elevate flap from radial to ulnar side to the brachioradialis tendon. Ligate and divide the radial artery and venae comitantes distally.
- incise the skin over the cephalic vein proximally to the cubital fossa. Identify the venous branching pattern and perforating vein.
- Elevate the skin and subcutaneous paddles proximally off of the FCR and brachioradialis.
- Define the venous anatomy at the cubital fossa. In most cases, the median basilic vein and continuation of the median vein contribution to the cephalic vein can be harvested proximal to the perforating vein. This anatomy allows two large veins to be harvested that drain both the deep and superficial systems. Occasionally, one large vein will be identified.
- Closure is performed by harvesting a 0.018-inch skin graft to cover the donor defect. The radial skin edge should be advanced to cover the exposed radial nerve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability of the flap
viability of the flap including color, warmth, capillary refill, smell and turgor
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start7 Feb 2024
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for for Upper Limb Soft Tissue CoverageStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelmawla Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319586
- Sponsor's protocol ID
- Soh-Med-24-02-08MS
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24126338Noaman 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.
PubMed 12375291Noaman 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.
PubMed 22397844Kaufman 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.
PubMed 16092819
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries
- ClinicalTrials.gov ID
- NCT06319586
- Acronym / sponsor ID
- Soh-Med-24-02-08MS
- Conditions
- for Upper Limb Soft Tissue Coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients aging 5 to 80 years.
- Soft Tissue defects following MCA injuries.
- Defect size less than 30 cm
Key exclusion criteria (5 listed)
- Peripheral vascular disease
- Underling bone osteomyelitis
- Unhealthy skin of volatile aspect of donor forearm
- Defect more than 30 cm
- Ulnar artery previous ligated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Forearm Flap* Elevate the flap from ulnar to radial side toward the FCR * Elevate flap from radial to ulnar side to the brachioradialis tendon. Ligate and divide the radial artery and venae comitantes distally. * incise the skin over the cephalic vein proximally to the cubital fossa. Identify the venous branching pattern and perforating vein. * Elevate the skin and subcutaneous paddles proximally off of the FCR and brachioradialis. * Define the venous anatomy at the cubital fossa. In most cases, the median basilic vein and continuation of the median vein contribution to the cephalic vein can be harvested proximal to the perforating vein. This anatomy allows two large veins to be harvested that drain both the deep and superficial systems. Occasionally, one large vein will be identified. * Closure is performed by harvesting a 0.018-inch skin graft to cover the donor defect. The radial skin edge should be advanced to cover the exposed radial nerve. | Procedure or surgery | – |
Primary outcome
Viability of the flap
Time frame: 12 months
viability of the flap including color, warmth, capillary refill, smell and turgor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 24126338Noaman 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.
- Background: PubMed 12375291Noaman 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.
- Background: PubMed 22397844Noaman 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.
- Background: PubMed 16092819Kaufman 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Forearm Flap in people with for Upper Limb Soft Tissue Coverage, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability of the flap (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06319586, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.