Surgical Wound, Tissue Adhesion
Conditions
Brief summary
To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.
Detailed description
The purpose of this study is compare skin closure via suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis. Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be reason to use tissue adhesives over traditional sutures. In these surgeries, there are five to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee opinion), so if the investigators can show significant time reduction for closure, that should reduce operative time and costs. To the investigators' knowledge, this will be the first study of its kind to make this comparison for urogynecologic robotic procedures.
Interventions
PROCEDURESubcuticular Skin Closure
We will only close the subcuticular layer with suture
DEVICETissue Adhesives
No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin
Sponsors
St. John Hospital & Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The evaluators of cosmesis will be blind to the group assignment. The person who will evaluate the scars will be a nurse or medical assistant.
Intervention model description
This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St. John Hospital and Medical Center from March 19, 2018 - November 30, 2018.
Exclusion criteria
* We will exclude women with active skin infections as they may contribute to poor wound healing and infections. We will also exclude procedures that are converted to laparotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incision Cosmesis | 12 weeks | Our primary outcome measure is to compare incision cosmesis between the two closure methods at the 12 week postoperative visit. The Stony Brook Scar Evaluation scale is used. A point is awarded in each of the following categories: width, height, color, hatch/suture marks, overall appearance. Poorer cosmesis is indicated by a lower score. Highest score possible is 5 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incision closure time | 30 minutes | The time of each closure method will be recorded and compared. |
Countries
United States
Outcome results
None listed