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Set-back Suture Versus Traditional Vertical Mattress Suture

Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01773447
Enrollment
47
Registered
2013-01-23
Start date
2011-08-31
Completion date
2014-04-30
Last updated
2017-03-31

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

Conditions

Basal Cell Carcinoma, Melanoma, Squamous Cell Carcinoma

Brief summary

The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.

Interventions

PROCEDURESet-back suture
PROCEDUREVertical mattress suture

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE

Eligibility

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

Inclusion criteria

* Elliptical surgical wound that needs to be closed with a layered closure * Wound 3 cm in length or longer

Exclusion criteria

* Incarceration * Active pregnancy * Less than 18 years of age * Unable to give informed consent * Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages) * Wound closure projected to be less than 3 cm in length * Skin less than 3 mm in thickness (dermis and epidermis combined)

Design outcomes

Primary

MeasureTime frameDescription
Scar width3 monthsWidth of scar in millimeters for each side of scar measured 1 cm from the midline.
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores3 monthsCompare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows: a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.

Secondary

MeasureTime frameDescription
Height of scar immediately following wound closure5 minutesHeight of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026