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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

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
  Purpose
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 Intervention
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
 Other: Hydrogen peroxide
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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.
Enrollment: 40
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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 
Study First Received: February 10, 2012
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 28, 2016