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Undermining During Cutaneous Wound Closure

Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289859
Enrollment
50
Registered
2014-11-13
Start date
2014-05-31
Completion date
2016-07-31
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Closure Techniques

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.

Interventions

PROCEDUREWound Closure with Undermining

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.

PROCEDUREWound Closure without Undermining

One side of the wound will remain un-undermined.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Scar on the Patient and Observer Scar Assessment Scale3 monthsAfter 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

MeasureTime frameDescription
Measurement of Scar Width3 monthsThe 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 Complications3 monthsNoting the presence or absence of bleeding, dehiscence, infection or spitting sutures.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026