Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Not Applicable

• Conditions: Weight Loss
• Interventions: Other: Running sutures; Other: Interrupted sutures

• 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

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-22
• Last Update Submitted: 2016-12-27
• Study First Posted: 2016-12-28
• Last Update Posted: 2016-12-29
• Primary Completion: 2017-12

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

Arm && Interventions

Group	Intervention	Description
Running sutures	Running sutures	Deep layers will be closed using running sutures
Interrupted sutures	Interrupted sutures	Deep layers will be closed using interrupted sutures

Primary Outcome Measures

Name	Time	Method
Scar cosmesis	6 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

Name	Time	Method
Adverse Events	6 months	Noting the presence or absence of dehiscence, infection or spitting sutures.
Time spent suturing the wound	up to 24h	The time spent suturing each half of the scar will be recorded in minutes
Number of suture thread needed	up to 24h	The number of threads used to suture each half of the scar will be recorded
Measurement of Scar Width	6 months	The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.

Trial Locations

Locations (1)

Saint Josph Hospital; 🇫🇷 Paris, France