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

NCT01143883 | Completed Results DMC

• 1 other identifier: Silverlon 108010
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Infections; Surgery

Keywords

All patients undergoing a colorectal resection; surgical site infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Silverlon Dressing

EXPERIMENTAL

The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.

Other: Silverlon

Standard of Care Dressing

ACTIVE COMPARATOR

The standard plain gauze is used to dress the wound postoperatively

Other: Standard of Care Dressing

Interventions

Silverlon OTHER

Silverlon dressings are gauze impregnated with silver ions

Silverlon Dressing

Standard of Care Dressing OTHER

Standard dry gauze dressing

Standard of Care Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jorge Marcet: lead

Study Sites (1)

Tampa General Hospital and University of South Florida Medical Clinics

Tampa, Florida, 33606, United States

Location

Related Publications (1)

• 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.

  PMID: 21730792 DERIVED

MeSH Terms

Conditions

Infections; Surgical Wound Infection

Interventions

silverlon

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Members of the surgical team were not blinded to the treatment group.

Results Point of Contact

• Title: Jorge E. Marcet, M.D.
• Organization: University of South Florida

jmateka@health.usf.edu

813-844-4545

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: June 14, 2010
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 13, 2013
• Results First Posted: June 13, 2013

Record last verified: 2013-06

Locations

US (1)