Set-back Suture Versus Traditional Vertical Mattress Suture

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773447
• Other study ID #: 247354
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: March 29, 2017
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: March 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Melanoma
• Squamous Cell Carcinoma

Intervention

Procedure:
• Set-back suture

• Vertical mattress suture

Locations

Country	Name	City	State
United States	UC Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	Scar width	Width of scar in millimeters for each side of scar measured 1 cm from the midline.	3 months
Secondary	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	5 minutes

External Links

•   University of California-Davis Department of Dermatology Clinical Research