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

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03425370
• Other study ID #: 1710792979
• Status: Terminated
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2018
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	West Virginia University University Town Centre Dermatology Clinic	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating the healing progression of the wound	By observation using the Patient-Observer Scar Assessment Scale (POSAS)	3 months after surgical wound closure
Primary	Rating the healing progression of the wound	By observation using the Patient-Observer Scar Assessment Scale (POSAS)	6 months after surgical wound closure