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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

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ClinicalTrials.gov Identifier: NCT01533675
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sutured Wounds Other: Hydrogen peroxide Other: Saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533675


Locations
United States, Florida
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Keyvan Nouri, Keyvan Nouri, M.D Professor of Dermatology, Ophthalmology & Otolaryngology, Chief of Dermatology Servic, University of Miami
ClinicalTrials.gov Identifier: NCT01533675     History of Changes
Other Study ID Numbers: # 20100301
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Keyvan Nouri, University of Miami:
suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics

Additional relevant MeSH terms:
Wounds and Injuries
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents