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

NCT03891004 | Completed DMC FDA Device

• 1 other identifier: StJohnHMedCtr
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound; Tissue Adhesion

Outcome Measures

Primary Outcomes (1)

• Incision Cosmesis

  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.

  12 weeks

Secondary Outcomes (1)

• Incision closure time

  30 minutes

Study Arms (2)

Tissue Adhesives Only

EXPERIMENTAL

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

Subcuticular Suture Closure Method Only

ACTIVE COMPARATOR

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

Interventions

Subcuticular Skin Closure PROCEDURE

We will only close the subcuticular layer with suture

Subcuticular Suture Closure Method Only

Tissue Adhesives DEVICE

No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin

Tissue Adhesives Only

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Only females as this pertains to skin closure of robotic urogynecology procedures
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. John Hospital & Medical Center: lead

Study Sites (1)

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

MeSH Terms

Conditions

Surgical Wound; Tissue Adhesions

Interventions

Tissue Adhesives

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 26, 2019
• Study Start: March 20, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

US (1)