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

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ClinicalTrials.gov Identifier: NCT03425370
Recruitment Status : Terminated (Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.)
First Posted : February 7, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Kolodney, 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.

Condition or disease Intervention/treatment Phase
Surgical Wound Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (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.
Primary Purpose: Other
Official Title: Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wound Side A: buried sutures, Wound Side B: tissue adhesive
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.
Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.

Experimental: Wound Side A: tissue adhesive, Wound Side B: buried 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.
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.




Primary Outcome Measures :
  1. Rating the healing progression of the wound [ Time Frame: 3 months after surgical wound closure ]
    By observation using the Patient-Observer Scar Assessment Scale (POSAS)

  2. Rating the healing progression of the wound [ Time Frame: 6 months after surgical wound closure ]
    By observation using the Patient-Observer Scar Assessment Scale (POSAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425370


Locations
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United States, West Virginia
West Virginia University University Town Centre Dermatology Clinic
Morgantown, West Virginia, United States, 26501
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: Michael S Kolodney, MD, PhD West Virginia University
  Study Documents (Full-Text)

Documents provided by Michael Kolodney, West Virginia University:

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Responsible Party: Michael Kolodney, Dermatology Section Chief, West Virginia University
ClinicalTrials.gov Identifier: NCT03425370     History of Changes
Other Study ID Numbers: 1710792979
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Kolodney, West Virginia University:
Surgical wounds
Tissue adhesive
Sutures
Wound healing
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries