Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

NCT03004274 | Unknown

• 1 other identifier: StJo-Paris-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Measurement of Scar Width

  3 months

• Measurement of Scar Width

  6 months

• Adverse Events

  15 days

• Adverse Events

  1.5 months

• Adverse Events

  3 months

Study Arms (2)

Running sutures

ACTIVE COMPARATOR

Deep layers will be closed using running sutures

Other: Running sutures

Interrupted sutures

EXPERIMENTAL

Deep layers will be closed using interrupted sutures

Other: Interrupted sutures

Interventions

Running sutures OTHER

Running sutures

Interrupted sutures OTHER

Interrupted sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years of age
• Subjects who are unable to understand the protocol or to give informed consent
• Subjects with mental illness

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead
• Fondation Hôpital Saint-Joseph: collaborator

Study Sites (1)

Saint Josph Hospital

Paris, Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 28, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

FR (1)