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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143883
• Other study ID #: Silverlon 108010
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: June 11, 2013
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections
• Surgery
• Surgical Wound Infection

Intervention

Other:
• Silverlon
Silverlon dressings are gauze impregnated with silver ions
• Standard of Care Dressing
Standard dry gauze dressing

Locations

Country	Name	City	State
United States	Tampa General Hospital and University of South Florida Medical Clinics	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jorge Marcet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No