Clinical trial NCT05864963: Medial Tab Flap for Soft Tissue Defects of the Leg
Official title: Medial Tab-type Fasciocutaneous Flap as an Alternative for the Management of Soft Tissue Defects of the Leg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leg Coverage Defects
Keywords: Lower extremity reconstruction
leg coverage defects
fasciocutaneous flaps
muscular flaps
orthoplastic
Lead sponsor: Fundación Campbell
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 216 patients with soft tissue defects on the anterior aspect of the leg underwent surgery during the study period, of these 18 patients were treated with medial tab-type fasciocutaneous flaps, this group constituted the intervention group. 198 underwent surgery with conventional flaps, of which 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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in surgical and healing time between medial tab flaps and conventional flaps
timeFrame: January 2019 - December 2022
Secondary outcomes:
measure: Sociodemographic and clinical characteristics
timeFrame: January 2019 - December 2022
measure: Complications
timeFrame: January 2019 - December 2022
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Fundacion Campbell
state: Atlantico
Study officials:
References:
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