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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Wound

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound Side A: buried sutures, Wound Side B: tissue adhesive<br>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.<br>* Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.<br>|
| Experimental: Wound Side A: tissue adhesive, Wound Side B: buried sutures<br>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.<br>* Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical wounds, Tissue adhesive, Sutures, Wound healing