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Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

Primary Purpose

Scarring

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Addition of Tie-Over Bolster Dressing
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scarring focused on measuring Tie-over Bolster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Dermatology
  • University of California, Davis - Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Layered Closure

Layered Closure with Tie-Over Bolster Dressing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
Width of Scar as measured using Trace-to-Tape Method
The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.
Complications or Adverse Events from Treatment
For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.

Full Information

First Posted
February 24, 2023
Last Updated
September 29, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05758168
Brief Title
Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds
Official Title
Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring
Keywords
Tie-over Bolster

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Two blinded observers will record their scores independently using the POSAS instrument.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Layered Closure
Arm Type
No Intervention
Arm Description
A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.
Arm Title
Layered Closure with Tie-Over Bolster Dressing
Arm Type
Experimental
Arm Description
The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.
Intervention Type
Procedure
Intervention Name(s)
Addition of Tie-Over Bolster Dressing
Intervention Description
Bolster will be sutured into place using peripheral non-absorbable anchoring sutures.
Primary Outcome Measure Information:
Title
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Description
This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
Time Frame
3 months
Title
Width of Scar as measured using Trace-to-Tape Method
Description
The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.
Time Frame
3 months
Title
Complications or Adverse Events from Treatment
Description
For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Calaguas, BS
Phone
916-551-2636
Email
accalaguas@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Vy, MD
Phone
916-816-1525
Email
mvy@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Organizational Affiliation
University of California, Davis - Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California, Davis - Dermatology Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Calaguas, BS
Phone
916-551-2636
Email
accalaguas@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Phone
916-551-2611
Email
dbeisen@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
First Name & Middle Initial & Last Name & Degree
Michelle Vy, MD
First Name & Middle Initial & Last Name & Degree
Zachary Kwapnoski, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21606834
Citation
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.
Results Reference
background
PubMed Identifier
29392093
Citation
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.
Results Reference
background
PubMed Identifier
24804638
Citation
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.
Results Reference
background
PubMed Identifier
24105084
Citation
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.
Results Reference
background
PubMed Identifier
28290607
Citation
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.
Results Reference
background
PubMed Identifier
12890464
Citation
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.
Results Reference
background
PubMed Identifier
31251960
Citation
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.
Results Reference
background

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Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

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