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

Not Applicable

Terminated

• Conditions: Surgical Wound
• Interventions: Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.

• Registration Number: NCT03425370
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-25
• Study Start: 2018-01-26
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Status Verified: 2018-10
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Side A: buried sutures, Wound Side B: tissue adhesive	Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.	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.
Wound Side A: tissue adhesive, Wound Side B: buried sutures	Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.	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.

Primary Outcome Measures

Name	Time	Method
Rating the healing progression of the wound	6 months after surgical wound closure	By observation using the Patient-Observer Scar Assessment Scale (POSAS)

Trial Locations

Locations (1)

West Virginia University University Town Centre Dermatology Clinic; 🇺🇸 Morgantown, West Virginia, United States