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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Keyvan Nouri, University of Miami

ClinicalTrials.gov Identifier:

NCT01533675

First received: February 10, 2012

Last updated: NA

Last verified: February 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 10, 2012
Last Updated Date	February 10, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2012)	Tensile strength of 4-0 nylon sutures [ Time Frame: 14 days ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	The Focus of This Study is to Determine if Hydrogen Peroxide Has an Effect of Suture Material Strength, When it is Applied as a Post-procedure Cleansing Agent
Intervention ^ICMJE	Other: Hydrogen peroxide Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator Other: Saline Once daily topical application of normal saline, using a cotton-tipped applicator
Study Arm (s)	Experimental: Hydrogen peroxide Intervention: Other: Hydrogen peroxide Active Comparator: Saline Intervention: Other: Saline
Publications *	Snyder CC. On the history of the suture. Plast Reconstr Surg. 1976 Oct;58(4):401-6. No abstract available. Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01533675
Other Study ID Numbers ^ICMJE	# 20100301
Has Data Monitoring Committee	No
Responsible Party	Keyvan Nouri, University of Miami
Study Sponsor ^ICMJE	University of Miami
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Miami
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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