Set-back Suture Versus Traditional Vertical Mattress Suture

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma; Basal Cell Carcinoma; Melanoma
• Interventions: Procedure: Set-back suture; Procedure: Vertical mattress suture

• Registration Number: NCT01773447
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Set-back suture	Set-back suture	Wound to be close by set-back suture technique.
Vertical mattress suture technique	Vertical mattress suture	Wound to be closed by vertical mattress technique.

Primary Outcome Measures

Name	Time	Method
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores	3 months	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.
Scar width	3 months	Width of scar in millimeters for each side of scar measured 1 cm from the midline.

Secondary Outcome Measures

Name	Time	Method
Height of scar immediately following wound closure	5 minutes	Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters

Trial Locations

Locations (1)

UC Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States