Undermining During Cutaneous Wound Closure
Primary Purpose
Wound Closure Techniques
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wound Closure with Undermining
Wound Closure without Undermining
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Closure Techniques
Eligibility Criteria
Inclusion Criteria:
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
Exclusion Criteria:
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds with diameter > 3 cm
- Wounds unable to be fully closed without undermining
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Wound Closure with Undermining
Wound Closure without Undermining
Arm Description
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
One side of the wound will remain un-undermined.
Outcomes
Primary Outcome Measures
Assessment of Scar on the Patient and Observer Scar Assessment Scale
After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Secondary Outcome Measures
Measurement of Scar Width
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Assessment of Complications
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Full Information
NCT ID
NCT02289859
First Posted
November 10, 2014
Last Updated
July 17, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02289859
Brief Title
Undermining During Cutaneous Wound Closure
Official Title
Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.
Detailed Description
The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Closure Techniques
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound Closure with Undermining
Arm Type
Active Comparator
Arm Description
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
Arm Title
Wound Closure without Undermining
Arm Type
Active Comparator
Arm Description
One side of the wound will remain un-undermined.
Intervention Type
Procedure
Intervention Name(s)
Wound Closure with Undermining
Intervention Description
The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
Intervention Type
Procedure
Intervention Name(s)
Wound Closure without Undermining
Intervention Description
One side of the wound will remain un-undermined.
Primary Outcome Measure Information:
Title
Assessment of Scar on the Patient and Observer Scar Assessment Scale
Description
After surgical procedure, half of the subject's wound will be closed after undermining, while the other half is closed without undermining. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measurement of Scar Width
Description
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Time Frame
3 months
Title
Assessment of Complications
Description
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to give informed consent themselves
Patient scheduled for cutaneous surgical procedure with predicted linear closure
Willing to return for follow up visits
Exclusion Criteria:
Mentally handicapped
Incarceration
Pregnant Women
Wounds with predicted closure length less than 3 cm
Wounds with diameter > 3 cm
Wounds unable to be fully closed without undermining
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34546436
Citation
Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
Results Reference
derived
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
Learn more about this trial
Undermining During Cutaneous Wound Closure
We'll reach out to this number within 24 hrs