Back to resultsA 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
Primary Purpose
Sutured Wounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrogen peroxide
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Sutured Wounds focused on measuring suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics
Eligibility 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
Sites / Locations
- University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrogen peroxide
Saline
Arm Description
Outcomes
Primary Outcome Measures
Tensile strength of 4-0 nylon sutures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01533675
Brief 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 Products
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sutured Wounds
Keywords
suture, tensile strength, wound care, saline, hydrogen peroxide, skin closure, wounds, wound healing, wound cleansing, antiseptics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen peroxide
Arm Type
Experimental
Arm Title
Saline
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Hydrogen peroxide
Intervention Description
Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Once daily topical application of normal saline, using a cotton-tipped applicator
Primary Outcome Measure Information:
Title
Tensile strength of 4-0 nylon sutures
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
785506
Citation
Snyder CC. On the history of the suture. Plast Reconstr Surg. 1976 Oct;58(4):401-6. doi: 10.1097/00006534-197610000-00001. No abstract available.
Results Reference
result
PubMed Identifier
19465201
Citation
Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
Results Reference
result
Learn more about this trial
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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