Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT05758168
Status
Recruiting
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Conditions

  • Scarring

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Addition of Tie-Over Bolster Dressing — PROCEDURE
    Bolster will be sutured into place using peripheral non-absorbable anchoring sutures.

Study Details

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.

Key Dates

Start date
Oct 10, 2023
Status verified
Apr 2026
Primary completion
Feb 25, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis - Dermatology DepartmentSacramentoCalifornia95816
Salsala Nasim, BS
[email protected]
916-551-2636
Daniel Eisen, MD
[email protected]
916-551-2611
Daniel Eisen, MD (PRINCIPAL_INVESTIGATOR)
Keemberly Kim, MD (SUB_INVESTIGATOR)
Zachary Kwapnoski, MD (SUB_INVESTIGATOR)

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By research site
University of California, Davis - Dermatology Department· Sacramento, CA

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