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Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures

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ClinicalTrials.gov Identifier: NCT03891004
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sunetris Fluellen, St. John Hospital & Medical Center

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Tissue Adhesion Procedure: Subcuticular Skin Closure Device: Tissue Adhesives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Tissue Adhesives Only
For the tissue adhesive, we will use Dermabond, which was FDA approved for skin closure in 1998. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.
Device: Tissue Adhesives
No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin

Active Comparator: Subcuticular Suture Closure Method Only
For the suture arm we will only close the subcuticular layer. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.
Procedure: Subcuticular Skin Closure
We will only close the subcuticular layer with suture




Primary Outcome Measures :
  1. Incision Cosmesis [ Time Frame: 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 Outcome Measures :
  1. Incision closure time [ Time Frame: 30 minutes ]
    The time of each closure method will be recorded and compared.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females as this pertains to skin closure of robotic urogynecology procedures
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891004


Locations
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United States, Michigan
St. John Hospital & Medical Center
Detroit, Michigan, United States, 48236
Sponsors and Collaborators
St. John Hospital & Medical Center

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Responsible Party: Sunetris Fluellen, Principal Investigator, St. John Hospital & Medical Center
ClinicalTrials.gov Identifier: NCT03891004     History of Changes
Other Study ID Numbers: StJohnHMedCtr
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Tissue Adhesions
Surgical Wound
Cicatrix
Fibrosis
Pathologic Processes
Wounds and Injuries