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
This clinical study is a prospective, randomized, controlled trial of patients undergoing elective colorectal surgical procedures that receive an abdominal skin incision of at least 6 cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4 Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators nor the participants will be blinded to the treatment modality after randomization.
Silver has long been known to have antimicrobial properties. It interacts with structural proteins and DNA, inhibiting bacterial replication and causing fatal structural changes within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing specifically designed for surgical wounds to prevent the development of surgical site infections. It is an easy to use product with no known microbial resistance or adverse effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in several retrospective studies but as of yet has not been tested in a prospective fashion. The objective of this study is to perform a prospective, randomized, clinical trial directly comparing the incidence of surgical site infections in patients treated with Silverlon® to standard postoperative dressing following elective colorectal surgery
|Condition or disease||Intervention/treatment||Phase|
|Infections Surgery||Other: Silverlon Other: Standard of Care Dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Silverlon Dressing
The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
Silverlon dressings are gauze impregnated with silver ions
Active Comparator: Standard of Care Dressing
The standard plain gauze is used to dress the wound postoperatively
Other: Standard of Care Dressing
Standard dry gauze dressing
- Surgical Site Infection [ Time Frame: Day of surgery up to 30 days post operatively ]We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.
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): NCT01143883
|United States, Florida|
|Tampa General Hospital and University of South Florida Medical Clinics|
|Tampa, Florida, United States, 33606|