Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study

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.

Study Overview

• Status: Unknown
• Conditions: Weight Loss
• Intervention / Treatment: Other: Running sutures; Other: Interrupted sutures

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Saint Josph Hospital
    • Contact: samer Jabbour, MD; Phone Number: +3384570068
    • Principal Investigator: samer Jabbour, MD
    • Principal Investigator: Taliah Schmitt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Running sutures; Deep layers will be closed using running sutures	Other: Running sutures
Experimental: Interrupted sutures; Deep layers will be closed using interrupted sutures	Other: Interrupted sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar cosmesis	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.	15 days
Scar cosmesis	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.	1.5 months
Scar cosmesis	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.	3 months
Scar cosmesis	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Scar Width	The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.	3 months
Measurement of Scar Width	The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.	6 months
Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	15 days
Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	1.5 months
Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	3 months
Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	6 months
Time spent suturing the wound	The time spent suturing each half of the scar will be recorded in minutes	up to 24h
Number of suture thread needed	The number of threads used to suture each half of the scar will be recorded	up to 24h

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Collaborators: Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 18, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 27, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: StJo-Paris-01