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:
University of Miami
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
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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:
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 |
| 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 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013