A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different Products

May 9, 2017 updated by: Keyvan Nouri, University of Miami

A Comparison Study of the Tensile Strength of Sutures Used in Dermatologic Surgery on the Day of Suture Removal, Following Wound Care With Two Different

Sutures are an integral part of surgery and available materials are diverse, as are the options for post-procedure care. Both saline and hydrogen peroxide are commonly used cleansing agents. This study aims to compare the effect of saline and hydrogen peroxide on the tensile strength of 4-0 nylon sutures following removal from a cutaneous surgical wound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is willing to comply with the informed consent procedures
  • Subject's wound is on the body or scalp
  • Subject will be able to come to the clinic for suture removal on day 14

Exclusion Criteria:

  • Subject is less than 18 years of age
  • Subject's wound was not closed with 4-0 nylon sutures
  • Subject's wound is on the face
  • Subject plans to apply other topicals to the area under study
  • Subject's suture is removed before or after day 14

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline
Other: Saline
Once daily topical application of normal saline, using a cotton-tipped applicator
Experimental: Hydrogen peroxide
Other: Hydrogen peroxide
Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tensile strength of 4-0 nylon sutures
Time Frame: 14 days
The tensile strength was defined as the force required to break the suture, with breaking strength as the maximum strength that a material can withstand when subjected to an applied load, without taking into consideration the cross sectional area. The strength of the sutures was measured using a tensometer.
14 days

Collaborators and Investigators

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

Sponsor

University of Miami

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.

General Publications

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

May 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # 20100301

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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