Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Primary Purpose
Surgical Wound
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.
Sponsored by
About this trial
This is an interventional other trial for Surgical Wound focused on measuring Surgical wounds, Tissue adhesive, Sutures, Wound healing
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
Sites / Locations
- West Virginia University University Town Centre Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Wound Side A: buried sutures, Wound Side B: tissue adhesive
Wound Side A: tissue adhesive, Wound Side B: buried sutures
Arm 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.
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.
Outcomes
Primary Outcome Measures
Rating the healing progression of the wound
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Rating the healing progression of the wound
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT03425370
First Posted
January 25, 2018
Last Updated
October 31, 2018
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT03425370
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
Surgical wounds, Tissue adhesive, Sutures, Wound healing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound Side A: buried sutures, Wound Side B: tissue adhesive
Arm Type
Experimental
Arm 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.
Arm Title
Wound Side A: tissue adhesive, Wound Side B: buried sutures
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.
Intervention Description
Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.
Primary Outcome Measure Information:
Title
Rating the healing progression of the wound
Description
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Time Frame
3 months after surgical wound closure
Title
Rating the healing progression of the wound
Description
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Time Frame
6 months after surgical wound closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Kolodney, MD, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University University Town Centre Dermatology Clinic
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
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