Clinical trial NCT03425370: Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Official title: Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound
Keywords: Surgical wounds
Tissue adhesive
Sutures
Wound healing
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rating the healing progression of the wound
timeFrame: 3 months after surgical wound closure
measure: Rating the healing progression of the wound
timeFrame: 6 months after surgical wound closure
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University University Town Centre Dermatology Clinic
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Michael S Kolodney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: