Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

NCT ID: NCT05758168

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-06-01

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.

Detailed Description

Following cutaneous surgical procedures, scar formation is inevitable. Reducing the degree of scar formation and achieving the best aesthetic outcome remains prominent within the dermatological literature. Recent research has highlighted the impact of mechanical forces and tension on scar formation, demonstrating that reducing the mechanical stress within the wound environment results in better aesthetic outcome (1,2). Tension-shielding devices have shown promise in scar reduction in both humans and porcine models (2). More recently, two clinical trials have shown that the use of an "embrace" device, a silicone-based dressing designed to minimize wound tension, effectively improves the aesthetic outcome following scar revision surgery (3,4). In addition, application of negative pressure via vacuum sealing drainage (VSD), commonly called a "wound-vac", has been consistently shown to accelerate wound healing (5). However, using these methods can be challenging, particularly due to cost, practicability, and patient compliance.

An alternative method for reducing mechanical stressors along scars has long been used within dermatologic surgery, namely the application of a bolster dressing.

For decades, tie-over bolster dressings have been employed following cutaneous procedures repaired with skin grafting. Typically, these bolsters are composed of Xeroform gauze (bismuth tribromophenate petrolatum-impregnated gauze) which are sutured on top of the graft. These have been shown to stabilize the graft, immobilize the wound bed, and reduce hematoma formation by delivering persistent downward pressure (6,7).

To our knowledge, the impact of scar cosmesis and rate of post-operative complications following the administration of tie-over bolster dressing over primary linear repair of surgical wounds have not been studied. This study seeks to determine the effectiveness of a tie-over bolster dressing in reducing tension to improve scar cosmesis by using individuals as their own controls in a split-scar model.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Layered Closure

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Addition of Tie-Over Bolster Dressing

Intervention Type: PROCEDURE

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

Interventions

Addition of Tie-Over Bolster Dressing

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis - Dermatology

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Salsala Nasim, BS

Role: CONTACT

sanasim@health.ucdavis.edu

916-551-2636

Keemberly Kim, MD

Role: CONTACT

keekim@ucdavis.edu

916-816-1525

Facility Contacts

Salsala Nasim, BS

Role: primary

sanasim@health.ucdavis.edu

916-551-2636

Daniel Eisen, MD

Role: backup

dbeisen@health.ucdavis.edu

916-551-2611

References

Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.

Reference Type: BACKGROUND

PMID: 21606834 (View on PubMed)

Barnes LA, Marshall CD, Leavitt T, Hu MS, Moore AL, Gonzalez JG, Longaker MT, Gurtner GC. Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):47-56. doi: 10.1089/wound.2016.0709.

Reference Type: BACKGROUND

PMID: 29392093 (View on PubMed)

Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.

Reference Type: BACKGROUND

PMID: 24804638 (View on PubMed)

Lim AF, Weintraub J, Kaplan EN, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC, Longaker MT. The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial. Plast Reconstr Surg. 2014 Feb;133(2):398-405. doi: 10.1097/01.prs.0000436526.64046.d0.

Reference Type: BACKGROUND

PMID: 24105084 (View on PubMed)

Liu J, Hu F, Tang J, Tang S, Xia K, Wu S, Yin C, Wang S, He Q, Xie H, Zhou J. Homemade-device-induced negative pressure promotes wound healing more efficiently than VSD-induced positive pressure by regulating inflammation, proliferation and remodeling. Int J Mol Med. 2017 Apr;39(4):879-888. doi: 10.3892/ijmm.2017.2919. Epub 2017 Mar 13.

Reference Type: BACKGROUND

PMID: 28290607 (View on PubMed)

Seymour FK, Giele HP. Tie-overs under pressure. Br J Plast Surg. 2003 Jul;56(5):494-7. doi: 10.1016/s0007-1226(03)00131-0.

Reference Type: BACKGROUND

PMID: 12890464 (View on PubMed)

Saikaly SK, Saikaly LE, Steadmon MJ. The 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. J Am Acad Dermatol. 2020 Nov;83(5):e335-e336. doi: 10.1016/j.jaad.2019.06.040. Epub 2019 Jun 25. No abstract available.

Reference Type: BACKGROUND

PMID: 31251960 (View on PubMed)

Other Identifiers

1977459

Identifier Type: -

Identifier Source: org_study_id