Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03004274
• Other study ID #: StJo-Paris-01
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2016
• Last updated: December 27, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Other:
• Running sutures

• Interrupted sutures

Locations

Country	Name	City	State
France	Saint Josph Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon	Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Measurement of Scar Width	The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.	3 months	No
Secondary	Measurement of Scar Width	The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.	6 months	No
Secondary	Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	15 days	No
Secondary	Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	1.5 months	No
Secondary	Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	3 months	No
Secondary	Adverse Events	Noting the presence or absence of dehiscence, infection or spitting sutures.	6 months	No
Secondary	Time spent suturing the wound	The time spent suturing each half of the scar will be recorded in minutes	up to 24h	No
Secondary	Number of suture thread needed	The number of threads used to suture each half of the scar will be recorded	up to 24h	No