Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05758168

Conditions

Scarring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Addition of Tie-Over Bolster Dressing

Study Details

Brief summary:

When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to stitch a small piece of a special gauze over the top of the regular stitches. This procedure is called a "tie-over bolster dressing." As the name implies, this extra dressing "bolsters" the wound closure so that the skin on each side of the cut stays in place.

The bolster dressing procedure has been used in the past in special cases, such as when skin grafts are necessary. The bolster dressing helps the skin graft heal by making sure the graft stays exactly in place. Keeping the wound stable with a bolster dressing also reduces bleeding under the wound. For non-grafted wounds, the bolster dressing procedure has not normally been used, and has not been well-studied. In this study the whole wound will be stitched normally and then the bolster dressing will be applied over half of the wound. This will allow us to see if the side with the bolster dressing heals with less scarring.

Conditions

Scarring

Study ID

NCT05758168

Start date

Oct 10, 2023

Status verified date

Apr, 2026

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Feb 25, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Incarceration
  • Under 18 years of age
  • Pregnant women
  • Unable to understand written and oral English Wounds with predicted closure length less than 3cm

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Layered Closure

A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.

experimental: Layered Closure with Tie-Over Bolster Dressing

The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.

Interventions

Addition of Tie-Over Bolster Dressing

Bolster will be sutured into place using peripheral non-absorbable anchoring sutures.

Primary outcome measure

  • Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

University of California, Davis - Dermatology Department

Recruiting

Sacramento, California, United States, 95816

Contacts

Principal Investigator:

Daniel Eisen, MD

More Information

Sponsor

University of California, Davis

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Tie-over Bolster

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-04-13.