NCT06885450

Brief 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 in the lower leg .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

March 11, 2025

Last Update Submit

March 18, 2025

Conditions

Soft Tissue DefectsPerforator Flap

Keywords

the lower legsoft tissue defectsperforator flapsdopper ultrasoundadvanced flaps

Outcome Measures

Primary Outcomes (1)

  • flaps observation

    flaps color ,temperature ,with or without effusion

    12-24months

Interventions

Perforator Pedicled FlapsPROCEDURE

Perforator Pedicled V-Y Advanced Flaps

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • people age: among 5-80years,
  • tolerate general anesthesia.
  • The perforating vessel is fine.

You may not qualify if:

  • patients age :\<5years,\>80years
  • can not tolerate general anesthesia.
  • The perforating vessel is damaged -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (2)

  • 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.

    PMID: 23616252BACKGROUND

  • Mendieta 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.

    PMID: 29922552BACKGROUND

Study Officials

  • the affiliated hospital of xuzhou medical university

    The Affiliated Hospital of Xuzhou Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 20, 2025

Study Start

April 1, 2018

Primary Completion

August 30, 2020

Study Completion

October 1, 2020

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)