Soft Tissue DefectsNCT06885450
Perforator Pedicled V-Y Advanced Flaps for Coverage in the Lower Limbs
An observational study of Soft Tissue Defects and Perforator Flap, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
Repair of soft tissue defects with hardware exposing in the lower limbs was considered as a severe challenge for plastic surgeons in reconstructive surgery. The purpose of the paper was to investigate the clinical effect of perforator pedicled V-Y advanced flap for repairing soft tissue defects with hardware exposing… Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Soft Tissue Defects, Perforator Flap
- What is being tested?
- Perforator Pedicled Flaps
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Oct 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: From April 2018 to August 2020, patients were hospitalized in the Department of Burns and Plastic Surgery of a regional hospital. All damages referred to the lower leg and soft tissue defects
Who may be able to join
- people age: among 5-80years,
- tolerate general anesthesia.
- The perforating vessel is fine.
Who cannot join
- patients age :<5years,>80years
- can not tolerate general anesthesia.
- The perforating vessel is damaged -
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: Perforator Pedicled V-Y Advanced Flaps for Coverage of Soft Tissue Defects in the Lower Limbs
Repair of soft tissue defects with hardware exposing in the lower limbs was considered as a severe challenge for plastic surgeons in reconstructive surgery. The purpose of the paper was to investigate the clinical effect of perforator pedicled V-Y advanced flap for repairing soft tissue defects with hardware exposing in the lower leg .
Read the detailed description
The various causes of the lower leg defects always consist of trauma, infection, tumors etc. Flaps are often used to cover the wounds when the bones and tendons are exposed to the body surface. However, flap coverage at the lower leg was considered a severe challenge due to the difficult anatomy and paucity of soft tissue1. Reconstruction and esthetic aspects of defect should be systemically considered .Common skin flaps include the peroneal perforator flap, the medial sural artery perforator flap2-8and muscle flaps. However, common skin flaps have a disadvantage of reversing of the pedicle which may be a reason of necrosis. A split thickness skin graft was usually applied to cover close secondary wound at the donor site. The aim of this paper was to investigate the clinical effect of V-Y advanced flaps based on septocutaneous and musculocutaneous perforator in the repair of soft-tissue wounds in the lower limbs.
- Conditions
- Soft Tissue Defects, Perforator Flap
- Being tested
- Perforator Pedicled Flaps
- Keywords
- the lower leg, soft tissue defects, perforator flaps, dopper ultrasound, advanced flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforator Pedicled FlapsProcedure or surgery
Perforator Pedicled V-Y Advanced Flaps
What is being measured
The primary outcome is the main question the study is designed to answer.
flaps observation
flaps color ,temperature ,with or without effusion
Measured: 12-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2018
- Primary completion30 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue DefectsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- the affiliated hospital of xuzhou medical university, Study chair, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885450
- Sponsor's protocol ID
- XYFY-SSZX
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi JW, Nam SY, Choi SH, Roh JL, Kim SY, Hong JP. Applications of medial sural perforator free flap for head and neck reconstructions. J Reconstr Microsurg. 2013 Sep;29(7):437-42. doi: 10.1055/s-0033-1343959. Epub 2013 Apr 24.
PubMed 23616252Mendieta M, Cabrera R, Siu A, Altamirano R, Gutierrez S. Perforator Propeller Flaps for the Coverage of Middle and Distal Leg Soft-tissue Defects. Plast Reconstr Surg Glob Open. 2018 May 2;6(5):e1759. doi: 10.1097/GOX.0000000000001759. eCollection 2018 May.
PubMed 29922552
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforator Pedicled V-Y Advanced Flaps for Coverage of Soft Tissue Defects in the Lower Limbs
- ClinicalTrials.gov ID
- NCT06885450
- Acronym / sponsor ID
- XYFY-SSZX
- Conditions
- Soft Tissue Defects, Perforator Flap
- Keywords
- the lower leg, soft tissue defects, perforator flaps, dopper ultrasound, advanced flaps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 20 Mar 2025 (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.
Repair of soft tissue defects with hardware exposing in the lower limbs was considered as a severe challenge for plastic surgeons in reconstructive surgery. The purpose of the paper was to investigate the clinical effect of perforator pedicled V-Y advanced flap for repairing soft tissue defects with hardware exposing in the lower leg .
Detailed description
The various causes of the lower leg defects always consist of trauma, infection, tumors etc. Flaps are often used to cover the wounds when the bones and tendons are exposed to the body surface. However, flap coverage at the lower leg was considered a severe challenge due to the difficult anatomy and paucity of soft tissue1. Reconstruction and esthetic aspects of defect should be systemically considered .Common skin flaps include the peroneal perforator flap, the medial sural artery perforator flap2-8and muscle flaps. However, common skin flaps have a disadvantage of reversing of the pedicle which may be a reason of necrosis. A split thickness skin graft was usually applied to cover close secondary wound at the donor site. The aim of this paper was to investigate the clinical effect of V-Y advanced flaps based on septocutaneous and musculocutaneous perforator in the repair of soft-tissue wounds in the lower limbs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From April 2018 to August 2020, patients were hospitalized in the Department of Burns and Plastic Surgery of a regional hospital. All damages referred to the lower leg and soft tissue defects
Key inclusion criteria (3 listed)
- people age: among 5-80years,
- tolerate general anesthesia.
- The perforating vessel is fine.
Key exclusion criteria (3 listed)
- patients age :<5years,>80years
- can not tolerate general anesthesia.
- The perforating vessel is damaged -
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 |
|---|---|---|
| Perforator Pedicled FlapsPerforator Pedicled V-Y Advanced Flaps | Procedure or surgery | – |
Primary outcome
flaps observation
Time frame: 12-24months
flaps color ,temperature ,with or without effusion
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 2025.
- Results publication: PubMed 23616252Choi JW, Nam SY, Choi SH, Roh JL, Kim SY, Hong JP. Applications of medial sural perforator free flap for head and neck reconstructions. J Reconstr Microsurg. 2013 Sep;29(7):437-42. doi: 10.1055/s-0033-1343959. Epub 2013 Apr 24.
- Results publication: PubMed 29922552Mendieta M, Cabrera R, Siu A, Altamirano R, Gutierrez S. Perforator Propeller Flaps for the Coverage of Middle and Distal Leg Soft-tissue Defects. Plast Reconstr Surg Glob Open. 2018 May 2;6(5):e1759. doi: 10.1097/GOX.0000000000001759. eCollection 2018 May.
- Individual participant dataSharing planned: No
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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 affiliated hospital of xuzhou medical university study chair
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Defects and Perforator Flap, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 3 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 2025. 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 China. 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?
flaps observation (time frame: 12-24months). 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 NCT06885450, which also lists 2 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 2025.