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Medial Tab Flap for Soft Tissue Defects of the Leg

F

Fundación Campbell

Status

Completed

Conditions

Leg Coverage Defects

Treatments

Procedure: Medial tab-type fasciocutaneous flap

Study type

Observational

Funder types

Other

Identifiers

NCT05864963
FC05052023

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

64 participants in 2 patient groups

Intervention group
Description:
18 patients treated with medial tab-type fasciocutaneous flaps
Treatment:
Procedure: Medial tab-type fasciocutaneous flap
Control group
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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