Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.

NCT03425370 | Terminated DMC

• 1 other identifier: 1710792979
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.

Conditions

Surgical Wound

Keywords

Surgical wounds; Tissue adhesive; Sutures; Wound healing

Outcome Measures

Primary Outcomes (2)

• Rating the healing progression of the wound

  By observation using the Patient-Observer Scar Assessment Scale (POSAS)

  3 months after surgical wound closure

• Rating the healing progression of the wound

  By observation using the Patient-Observer Scar Assessment Scale (POSAS)

  6 months after surgical wound closure

Study Arms (2)

Wound Side A: buried sutures, Wound Side B: tissue adhesive

EXPERIMENTAL

Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.

Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

Wound Side A: tissue adhesive, Wound Side B: buried sutures

EXPERIMENTAL

Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.

Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

Interventions

Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. PROCEDURE

Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.

Wound Side A: buried sutures, Wound Side B: tissue adhesive; Wound Side A: tissue adhesive, Wound Side B: buried sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
• Willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery

You may not qualify if:

• Pregnant
• Unable to understand English
• Mentally impaired
• Incarcerated
• Has nonlinear closures

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University University Town Centre Dermatology Clinic

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michael S Kolodney, MD, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The efficacy of intervention methods will be assessed at the 3 month and 6 month follow-ups by having the patient and two blinded observers rate the healing progression of the wound using the POSAS. The observers will be either dermatology faculty or dermatology. The POSAS is a standard metric in measuring wound healing in cutaneous surgery studies since it does not require training but takes into account the scar assessment of the patient and observers. Subsequently, the height and width of the scar will be measured and compared to the surrounding unaffected skin. The assessments of the two blind observers will be averaged.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Section Chief

Model Details: Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. The nurse will refer to the randomization list and inform the surgeon which side of the wound will receive tissue glue and which side will receive deep sutures. Following common practice of wound labeling, side A will always be left or superior from the surgeon's perspective, whereas side B will always be right or inferior from the surgeon's perspective. Per randomization, half of the wound will be closed with deep absorbable sutures followed by superficial non-absorbable sutures. The other half of the wound will be closed with superficial non-absorbable sutures followed by tissue glue (Dermabond). Tissue glue will be spread to cover an area extending one cm from the wound margin on both sides.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 7, 2018
• Study Start: January 26, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)