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Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Not Applicable
Conditions
Weight Loss
Registration Number
NCT03004274
Lead Sponsor
St Joseph University, Beirut, Lebanon
Brief Summary

The goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Age 18 and over
  • Brachioplasty, Tighplasty, abdominoplasty, circumferential dermolipectomy in a massive weight loss patient
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Exclusion Criteria
  • Under 18 years of age
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Scar cosmesis6 months

The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.

Secondary Outcome Measures
NameTimeMethod
Time spent suturing the woundup to 24h

The time spent suturing each half of the scar will be recorded in minutes

Measurement of Scar Width6 months

The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.

Adverse Events6 months

Noting the presence or absence of dehiscence, infection or spitting sutures.

Number of suture thread neededup to 24h

The number of threads used to suture each half of the scar will be recorded

Trial Locations

Locations (1)

Saint Josph Hospital

🇫🇷

Paris, France

Saint Josph Hospital
🇫🇷Paris, France

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