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Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Running sutures
Interrupted sutures
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Josph HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Running sutures

Interrupted sutures

Arm Description

Deep layers will be closed using running sutures

Deep layers will be closed using interrupted sutures

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2016
Last Updated
December 27, 2016
Sponsor
St Joseph University, Beirut, Lebanon
Collaborators
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03004274
Brief Title
Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients
Official Title
Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon
Collaborators
Fondation Hôpital Saint-Joseph

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Running sutures
Arm Type
Active Comparator
Arm Description
Deep layers will be closed using running sutures
Arm Title
Interrupted sutures
Arm Type
Experimental
Arm Description
Deep layers will be closed using interrupted sutures
Intervention Type
Other
Intervention Name(s)
Running sutures
Intervention Type
Other
Intervention Name(s)
Interrupted sutures
Primary Outcome Measure Information:
Title
Scar cosmesis
Description
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.
Time Frame
15 days
Title
Scar cosmesis
Description
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.
Time Frame
1.5 months
Title
Scar cosmesis
Description
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.
Time Frame
3 months
Title
Scar cosmesis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measurement of Scar Width
Description
The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.
Time Frame
3 months
Title
Measurement of Scar Width
Description
The width of the scar will be measured 10 centimeter from the midline on both scar-halfs.
Time Frame
6 months
Title
Adverse Events
Description
Noting the presence or absence of dehiscence, infection or spitting sutures.
Time Frame
15 days
Title
Adverse Events
Description
Noting the presence or absence of dehiscence, infection or spitting sutures.
Time Frame
1.5 months
Title
Adverse Events
Description
Noting the presence or absence of dehiscence, infection or spitting sutures.
Time Frame
3 months
Title
Adverse Events
Description
Noting the presence or absence of dehiscence, infection or spitting sutures.
Time Frame
6 months
Title
Time spent suturing the wound
Description
The time spent suturing each half of the scar will be recorded in minutes
Time Frame
up to 24h
Title
Number of suture thread needed
Description
The number of threads used to suture each half of the scar will be recorded
Time Frame
up to 24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Josph Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
samer Jabbour, MD
Phone
+3384570068
First Name & Middle Initial & Last Name & Degree
samer Jabbour, MD
First Name & Middle Initial & Last Name & Degree
Taliah Schmitt, MD

12. IPD Sharing Statement

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Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

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