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Tie-Over Bolster Dressing for Surgical Scars

N/A
Recruiting
Led By Daniel Eisen, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to close wounds to reduce scarring: using a special gauze to reduce tension around the wound.

Who is the study for?
This trial is for adults over 18 who are having surgery on their head or neck and can close the wound right away. They must be able to consent and come back for a check-up. It's not for those with small wounds, under 18s, prisoners, pregnant women, or those who don't understand English.
What is being tested?
The study tests if adding a 'tie-over bolster dressing'—a special gauze stitched over regular stitches—on half of the surgical wound reduces scarring compared to just stitches alone.
What are the potential side effects?
Potential side effects may include discomfort from the extra dressing, possible skin irritation at the bolster site, and rare chances of infection due to additional material on the wound.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Secondary study objectives
Complications or Adverse Events from Treatment
Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Width of Scar as measured using Trace-to-Tape Method

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Layered Closure with Tie-Over Bolster DressingExperimental Treatment1 Intervention
The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.
Group II: Layered ClosureActive Control1 Intervention
A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
944 Previous Clinical Trials
4,755,912 Total Patients Enrolled
Daniel Eisen, MDPrincipal InvestigatorUniversity of California, Davis - Dermatology
10 Previous Clinical Trials
577 Total Patients Enrolled

Media Library

Layered Closure with Tie-Over Bolster Dressing Clinical Trial Eligibility Overview. Trial Name: NCT05758168 — N/A
Scar tissue Research Study Groups: Layered Closure, Layered Closure with Tie-Over Bolster Dressing
Scar tissue Clinical Trial 2023: Layered Closure with Tie-Over Bolster Dressing Highlights & Side Effects. Trial Name: NCT05758168 — N/A
Layered Closure with Tie-Over Bolster Dressing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05758168 — N/A
~4 spots leftby Dec 2024
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