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Study Looking at the Effect of Silverlon on Post Operative Wound Infections

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ClinicalTrials.gov Identifier: NCT01143883
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : June 13, 2013
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Jorge Marcet, University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Infections
Surgery
Interventions Other: Silverlon
Other: Standard of Care Dressing
Enrollment 110
Recruitment Details All 110 patients were consented for this study during their pre-operative visit.
Pre-assignment Details  
Arm/Group Title Silverlon Dressing Standard of Care Dressing
Hide Arm/Group Description The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon. The standard plain gauze is used to dress the wound postoperatively
Period Title: Overall Study
Started 55 55
Completed 55 55
Not Completed 0 0
Arm/Group Title Silverlon Dressing Standard of Care Dressing Total
Hide Arm/Group Description 55 55 Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
<=18 years
0
   0.0%
3
   5.5%
3
   2.7%
Between 18 and 65 years
45
  81.8%
4
   7.3%
49
  44.5%
>=65 years
10
  18.2%
48
  87.3%
58
  52.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
62  (15.6) 58  (11.1) 60  (13.7)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female 27 28 55
Male 28 26 54
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 55 participants 110 participants
55 55 110
1.Primary Outcome
Title Surgical Site Infection
Hide Description We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.
Time Frame Day of surgery up to 30 days post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol
Arm/Group Title Silverlon Dressing Standard of Care Dressing
Hide Arm/Group Description:
55
55
Overall Number of Participants Analyzed 55 54
Measure Type: Number
Unit of Measure: percentage of participants with SSI
13 33
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silverlon Dressing Standard of Care Dressing
Hide Arm/Group Description 55 55
All-Cause Mortality
Silverlon Dressing Standard of Care Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Silverlon Dressing Standard of Care Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.82%
Silverlon Dressing Standard of Care Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   1/55 (1.82%)   0/55 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash [1]  1/55 (1.82%)  0/55 (0.00%) 
[1]
Rash resolved after dressing removed
Members of the surgical team were not blinded to the treatment group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jorge E. Marcet, M.D.
Organization: University of South Florida
Phone: 813-844-4545
EMail: jmateka@health.usf.edu
Layout table for additonal information
Responsible Party: Jorge Marcet, University of South Florida
ClinicalTrials.gov Identifier: NCT01143883     History of Changes
Other Study ID Numbers: Silverlon 108010
First Submitted: March 24, 2010
First Posted: June 14, 2010
Results First Submitted: December 10, 2012
Results First Posted: June 13, 2013
Last Update Posted: June 13, 2013