Medial Tab Flap for Soft Tissue Defects of the Leg

Study Overview
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Brief Summary
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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.

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

Conditions
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Leg Coverage Defects

Intervention / Treatment
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* Procedure: Medial tab-type fasciocutaneous flap


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>18 patients treated with medial tab-type fasciocutaneous flaps | Procedure: Medial tab-type fasciocutaneous flap<br>* 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.<br>|
| Control group<br>46 patients were randomly chosen, through Propensity Score Matching (PSM) the matching was performed with the age variable. The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13 with a gastrocnemius flap | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in surgical and healing time between medial tab flaps and conventional flaps | 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 | January 2019 - December 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic and clinical characteristics | The data collection was made from the Sculapio software clinical records of the Fundacion Campbell | January 2019 - December 2022 | 
| Complications | 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. | January 2019 - December 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower extremity reconstruction, leg coverage defects, fasciocutaneous flaps, muscular flaps, orthoplastic