Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients

Study Overview
=================
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.

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

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Other: Running sutures
* Other: Interrupted sutures


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Running sutures<br>Deep layers will be closed using running sutures | Other: Running sutures<br> <br> |
| Experimental: Interrupted sutures<br>Deep layers will be closed using interrupted sutures | Other: Interrupted sutures<br> <br> |

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 |