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CompletedNCT01773447Updated Mar 31, 2017

Set-back Suture Versus Traditional Vertical Mattress Suture

An interventional study of Set-back suture and Vertical mattress suture in Basal Cell Carcinoma, Squamous Cell Carcinoma and Melanoma, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-31.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Melanoma
03

In context

Carcinoma, Basal Cell

369 studies on the registry are indexed under Carcinoma, Basal Cell; 65 are open to participants now.

This study's planned enrollment of 47 is above the median of 41 across 262 interventional studies indexed under Carcinoma, Basal Cell.

Browse Carcinoma, Basal Cell studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
47 participants (estimated)

Study arms

  • Active comparator
    Set-back suture

    Wound to be close by set-back suture technique.

    Procedure: Set-back suture

  • Active comparator
    Vertical mattress suture technique

    Wound to be closed by vertical mattress technique.

    Procedure: Vertical mattress suture

Interventions

  • ProcedureSet-back suture
  • ProcedureVertical mattress suture
06

What researchers measure

Primary outcomes

  1. Mean of sum of 2 blinded reviewers Physician Observer Assessment scores

    Compare 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.

    Time frame: 3 months

  2. Scar width

    Width of scar in millimeters for each side of scar measured 1 cm from the midline.

    Time frame: 3 months

Secondary outcomes

  1. Height of scar immediately following wound closure

    Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters

    Time frame: 5 minutes

07

Study locations

1 site
  • UC Davis, Department of Dermatology
    Sacramento, California 95816, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01773447
Responsible party
Sponsor
First posted
Jan 23, 2013
Start date
Aug 2011
Primary completion
Mar 2014
Completion
Apr 2014
Last update
Mar 31, 2017

Study contacts

Daniel Eisen, M.D.
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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