Set-back Suture Versus Traditional Vertical Mattress Suture

March 29, 2017 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height of scar immediately following wound closure
Time Frame: 5 minutes
Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 247354

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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