Set-back Suture Versus Traditional Vertical Mattress Suture

NCT ID: NCT01773447

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma; Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Set-back suture

Wound to be close by set-back suture technique.

Group Type: ACTIVE_COMPARATOR

Set-back suture

Intervention Type: PROCEDURE

Vertical mattress suture technique

Wound to be closed by vertical mattress technique.

Group Type: ACTIVE_COMPARATOR

Vertical mattress suture

Intervention Type: PROCEDURE

Interventions

Set-back suture

Intervention Type: PROCEDURE

Vertical mattress suture

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis, Department of Dermatology

Sacramento, California, United States

Countries

United States

Related Links

http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

247354

Identifier Type: -

Identifier Source: org_study_id