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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

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Silverlon Dressing
The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
Other: Silverlon
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients undergoing elective colorectal surgery by a trained colorectal surgeon with an abdominal skin incision of at least 3 cm
  2. Patients that are willing and able to comply with the requirements of the protocol including follow-up requirements
  3. Patients willing and able to sign a study specific informed consent

Exclusion Criteria:

  1. Patients that fail to meet the skin incision size criteria
  2. Patients with a known allergy to silver
  3. Patients less than 18 years of age
  4. Any contraindication to undergoing a surgical procedure under general anesthesia
  5. Patients with preoperative evidence of a current abdominal wall infection/surgical site infection from a previous laparotomy/laparoscopy
  6. Patients that have received antibiotic therapy within the week prior to surgery
  7. Patients with preoperative evaluation suggestive of an intra-abdominal process that would preclude full closure of the skin
  8. Patients with a previously placed anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure
  9. Women who are pregnant or breast feeding or are considering becoming pregnant during the follow-up period
  10. Mental incompetence as determined by the Investigator which would affect participation in the study
  11. Concurrently participating in any other investigational study

Information from the National Library of Medicine

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


Locations
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United States, Florida
Tampa General Hospital and University of South Florida Medical Clinics
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Jorge Marcet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jorge Marcet, Professor, Department of Surgery, University of South Florida
ClinicalTrials.gov Identifier: NCT01143883     History of Changes
Other Study ID Numbers: Silverlon 108010
First Posted: June 14, 2010    Key Record Dates
Results First Posted: June 13, 2013
Last Update Posted: June 13, 2013
Last Verified: June 2013
Keywords provided by Jorge Marcet, University of South Florida:
All patients undergoing a colorectal resection
surgical site infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases