Medial Tab Flap for Soft Tissue Defects of the Leg

Completed

• Conditions: Leg Coverage Defects

• Registration Number: NCT05864963
• Lead Sponsor: Fundación Campbell

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-20
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in surgical and healing time between medial tab flaps and conventional flaps	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 Outcome Measures

Name	Time	Method
Sociodemographic and clinical characteristics	January 2019 - December 2022	The data collection was made from the Sculapio software clinical records of the Fundacion Campbell
Complications	January 2019 - December 2022	The complications were descripted from the clinic history recorded by the orthopedic surgeon specialist, the following pathologies were taken into account: necrosis, suture dehiscence, fistula, foreign body granuloma, enlargement of the defect and infection.

Trial Locations

Locations (1)

Fundacion Campbell; 🇨🇴 Barranquilla, Atlantico, Colombia