Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

NCT05758168 | Recruiting

• 1 other identifier: 1977459
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Tie-over Bolster

Outcome Measures

Primary Outcomes (1)

• Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  3 months

Secondary Outcomes (3)

• Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  3 months

• Width of Scar as measured using Trace-to-Tape Method

  3 months

• Complications or Adverse Events from Treatment

  3 months

Study Arms (2)

Layered Closure

NO INTERVENTION

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

Layered Closure with Tie-Over Bolster Dressing

EXPERIMENTAL

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

Procedure: Addition of Tie-Over Bolster Dressing

Interventions

Addition of Tie-Over Bolster Dressing PROCEDURE

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

Layered Closure with Tie-Over Bolster Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 21606834 BACKGROUND

• 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.

  PMID: 29392093 BACKGROUND

• 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.

  PMID: 24804638 BACKGROUND

• 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.

  PMID: 24105084 BACKGROUND

• 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.

  PMID: 28290607 BACKGROUND

• 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.

  PMID: 12890464 BACKGROUND

• 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.

  PMID: 31251960 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Eisen, MD

  University of California, Davis - Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salsala Nasim, BS

CONTACT

916-551-2636; sanasim@health.ucdavis.edu

Keemberly Kim, MD

CONTACT

916-816-1525; keekim@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two blinded observers will record their scores independently using the POSAS instrument.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: October 10, 2023
• Primary Completion: February 25, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)