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

A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery

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

Study Overview

• Status: Completed
• Conditions: Infections; Surgery
• Intervention / Treatment: Other: Silverlon; Other: Standard of Care Dressing

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital and University of South Florida Medical Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection	We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.	Day of surgery up to 30 days post operatively

Collaborators and Investigators

• Sponsor: Jorge Marcet

Publications and helpful links

General Publications

• Krieger BR, Davis DM, Sanchez JE, Mateka JJ, Nfonsam VN, Frattini JC, Marcet JE. The use of silver nylon in preventing surgical site infections following colon and rectal surgery. Dis Colon Rectum. 2011 Aug;54(8):1014-9. doi: 10.1097/DCR.0b013e31821c495d.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (ESTIMATE): June 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: surgical site infections; All patients undergoing a colorectal resection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Silverlon 108010