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Clinical Trials/NCT05864963
NCT05864963
Completed
Not Applicable

Medial Tab-type Fasciocutaneous Flap as an Alternative for the Management of Soft Tissue Defects of the Leg

Fundación Campbell1 site in 1 country64 target enrollmentJanuary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leg Coverage Defects
Sponsor
Fundación Campbell
Enrollment
64
Locations
1
Primary Endpoint
Differences in surgical and healing time between medial tab flaps and conventional flaps
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient.

Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue reconstruction on the leg, compared to conventional flaps.

Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64 patients with soft tissue defects were selected and followed up to one year postoperatively. Outcome variables: surgical time in minutes, healing, healing time in days, complications.

Registry
clinicaltrials.gov
Start Date
January 20, 2019
End Date
December 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación Campbell
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of soft tissue defects in the leg due to grade III B open fractures, or due to bone infection
  • contraindication to using conventional flaps due to the following reasons: soft tissue injuries at the flap island site, injury to the vascular bed of the flap or injury of the flap structure (fascia, skin or muscle)
  • people between 18 and 70 years of age

Exclusion Criteria

  • Patients with a history of free flaps
  • Whose clinical follow up couldn't be completed to assess outcomes were excluded.

Outcomes

Primary Outcomes

Differences in surgical and healing time between medial tab flaps and conventional flaps

Time Frame: January 2019 - December 2022

This information was taken from he Sculapio software clinical records, the surgical time was measured in minutes from the moment of the incision to the clousure of the surgical planes, and the healing time was measured in days from the immediate postoperative period until the wound epithelization

Secondary Outcomes

  • Sociodemographic and clinical characteristics(January 2019 - December 2022)
  • Complications(January 2019 - December 2022)

Study Sites (1)

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