Completed

NCT Number: NCT05864963

Medial Tab Flap for Soft Tissue Defects of the Leg

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.

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Key information

Conditions

Leg Coverage Defects

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Campbell

Barranquilla, Atlántico, 080001, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medial tab-type fasciocutaneous flap

Procedure

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.

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

Time frame: January 2019 - December 2022

The data collection was made from the Sculapio software clinical records of the Fundacion Campbell
Complications

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación Campbell

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 18, 2023
Registry last updated: May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.