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Undermining Apices in Surgical Wounds

Primary Purpose

Scarring

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apical Undermining
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scarring

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 neck, trunk, and extremities 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

  • University of California, Davis - Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Linear Wound Closure

Linear Wound Closure with Apical Undermining

Arm Description

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

The other side of the wound will have a cutaneous layer of sutures, as is standard of care, and will receive apical undermining.

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
NCT05758181
Brief Title
Undermining Apices in Surgical Wounds
Official Title
Undermining Apices 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
Enrolling by invitation
Study Start Date
August 9, 2023 (Actual)
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 neck, trunk, arms, or legs, 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 free up the skin around the wound. This procedure is also called "undermining". Some studies have shown that freeing up the skin near the tips of the wound, called the "apices," is helpful for improving the cosmetic outcome of scars. This study will investigate if there are any differences in the appearances of the scar if one tip is undermined and the other is not.
Detailed Description
Reducing scar tissue formation and postoperative complications in wound closure has remained the focus of recent studies and decreases the cost and time burden of follow-up visits and procedures. Such studies have 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 outcomes. Undermining peripheral and apices of the wound has been used in the closure of large and tight defects allowing the closure of these wounds by reducing the tension. Undermining has been shown to reduce tension, and peripheral and apical undermining has been recommended for decreasing scar formation. However, extensive undermining may increase the complications of the surgery by reducing vascularization and creating a space for hematomas. To our knowledge, the impact of scar cosmesis and the rate of postoperative complications in apical undermining in the linear repair of surgical wounds have not been studied, and it remains unknown whether undermining the apices can decrease the protrusion of the scar tissue at the edges. This study seeks to determine the effectiveness of apical undermining of linear wound closures in improving scar cosmesis by using individuals as their own controls in a split-scar model. This is a single center, randomized, evaluator-blinded, split wound study. After screening and informed consent, demographic data will be collected including age, race, gender, and medical record number. This will be collected within the Redcap database. The patient's wound will be labeled A if it is on the left or superior side of the investigator and B if it is on the right or inferior side. A concealed randomization result will be obtained from the Redcap randomization module, which will specify which side, A or B, will receive apical undermining Following this, both sides of the wound will be sutured together with a subcutaneous (bottom) layer of stitches. Next, a cutaneous layer of sutures will be placed, as is the standard of care. A digital image of the wound after the epidermal closure will be obtained; these may be used in scientific talks and/or for publication purposes. The patient will then be instructed to continue dressing changes along the entire length of the surgical site until the wound is fully healed as is the standard of care. Treatment assignment, wound length, demographic data, and digital images will be recorded within the Redcap database. Follow-up assessment will be scheduled for three months following the procedure, with a one-month window before or after that time if the patient cannot return at precisely three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring

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
Linear Wound Closure
Arm Type
No Intervention
Arm Description
A cutaneous layer of sutures will be placed on one side, as is standard of care.
Arm Title
Linear Wound Closure with Apical Undermining
Arm Type
Experimental
Arm Description
The other side of the wound will have a cutaneous layer of sutures, as is standard of care, and will receive apical undermining.
Intervention Type
Other
Intervention Name(s)
Apical Undermining
Intervention Description
The skin at the tip of the wound will be freed to reduce tension.
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 neck, trunk, and extremities 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
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
University of California, Davis - Dermatology Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

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
27536478
Citation
Krishnan NM, Brown BJ, Davison SP, Mauskar N, Mino M, Jordan MH, Shupp JW. Reducing Wound Tension with Undermining or Imbrication-Do They Work? Plast Reconstr Surg Glob Open. 2016 Jul 13;4(7):e799. doi: 10.1097/GOX.0000000000000799. eCollection 2016 Jul.
Results Reference
background
PubMed Identifier
2405023
Citation
Zitelli JA. TIPS for a better ellipse. J Am Acad Dermatol. 1990 Jan;22(1):101-3. doi: 10.1016/0190-9622(90)70016-b.
Results Reference
background
Citation
Jonathan K (Ed). Dermatologic Surgery. McGraw-Hill Education. 2018. ISBN: 978-1-25-964392-7.
Results Reference
background

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Undermining Apices in Surgical Wounds

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