CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Medial tab-type fasciocutaneous flapprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05864963
NCT05864963N/ACompleted

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

Fundación Campbell·observational·Posted May 18, 2023·Updated May 18, 2023

In Brief

An observational study evaluating Medial tab-type fasciocutaneous flap for Leg Coverage Defects. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesColombia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 18, 2023
Enrollment StartJan 20, 2019
Primary CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 3.1 years ago

Interventions

Medial tab-type fasciocutaneous flapprocedure

The flap can be taken in different ways depending on the defect. Once the base of the flap is identified, the posterior edge of the tibia is taken as reference; marking of the tab is performed considering that the posterior incision is located 5 cm from the posterior edge of the tibia, and the anterior incision is located longitudinally of the medial region of the tibial diaphysis, the length of the incision depends on the base of the flap and the defect's size. The posterior incision is made first in the skin, subcutaneous cellular tissue until the fascia is identified; the subfascial flap is dissected to avoid injuring perforators, dissection is completed up to the anterior edge of the flap, if needed direct cutaneous perforators are ligated; once the subfascial plane has been identified and dissected, the tab is completed in its proximal or distal part according to the previous surgical planning. Later, the tab is rotated to the anterior region of the tibia to cover the defect.