Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies.
Geoffrey C Gurtner, Reinhold H Dauskardt, Victor W Wong...
https://pubmed.ncbi.nlm.nih.gov/21606834Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05758168
Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
Led by University of California, Davis · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the use of a tie-over bolster dressing to reduce scarring after surgery on the head and face. Researchers want to see if applying this special gauze over stitches on half of a surgical wound can improve healing and reduce scar formation. The study focuses on patients undergoing cutaneous surgery with primary closure on the head or neck, aiming to compare traditional stitches with this bolster dressing method. Participants will have their surgical wound closed with standard stitches on one side, while the other side will receive stitches plus a tie-over bolster dressing secured by non-absorbable sutures. This bolster applies pressure to stabilize the wound and reduce tension, which may help minimize scar appearance. The study uses a randomized, single-blind, split-wound design, allowing each participant to serve as their own control. During the study, participants will be assessed at 3 months post-surgery using the Patient Observer Scar Assessment Score (POSAS) to evaluate scar appearance from both observer and patient perspectives. Scar width will also be measured, and any complications or adverse events related to treatment will be recorded. Participants must be willing to return for follow-up visits to complete these outcome assessments and monitor healing progress.
CONDITIONS
Brief Title
Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure on the head or neck with predicted primary closure
- Willing to return for follow-up visit
You will not qualify if you...
- Incarceration
- Under 18 years of age
- Pregnant women
- Unable to understand written and oral English
- Wounds with predicted closure length less than 3cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single surgical procedure with post-operative care until wound closure
Participants undergo a cutaneous surgical procedure where one side of the wound receives standard layered closure sutures and the other side receives layered closure with a tie-over bolster dressing applied.
1 surgical visit and approximately 1 follow-up visit
Follow-up
Duration - Up to 3 months after surgery
Participants return for follow-up visits to assess scar appearance, measure scar width, and monitor for any complications or adverse events related to the treatment.
At least 1 follow-up visit around 3 months post-surgery
Trial Site Locations
Total: 1 location
1
University of California, Davis - Dermatology Department
Sacramento, California, United States, 95816
Actively Recruiting
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Research Team
S
Salsala Nasim, BS
K
Keemberly Kim, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation.
Leandra A Barnes, Clement D Marshall, Tripp Leavitt...
https://pubmed.ncbi.nlm.nih.gov/29392093A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.
Michael T Longaker, Rod J Rohrich, Lauren Greenberg...
https://pubmed.ncbi.nlm.nih.gov/24804638The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial.
Angeline F Lim, Jennifer Weintraub, Ernest N Kaplan...
https://pubmed.ncbi.nlm.nih.gov/24105084Homemade-device-induced negative pressure promotes wound healing more efficiently than VSD-induced positive pressure by regulating inflammation, proliferation and remodeling.
Jinyan Liu, Feng Hu, Jintian Tang...
https://pubmed.ncbi.nlm.nih.gov/28290607Tie-overs under pressure.
F K Seymour, H P Giele
https://pubmed.ncbi.nlm.nih.gov/12890464The use of a horizontal mattress suture and notches in 3% bismuth tribromophenate-impregnated petrolatum gauze tie-over bolster dressings to improve surgical outcomes after skin grafts.
Sami Kameel Saikaly, Lara Elizabeth Saikaly, Matthew Jordan Steadmon
https://pubmed.ncbi.nlm.nih.gov/31251960