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

Completed · Not applicable

Conditions studied: Infections, Surgery

In brief

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

Key facts

Study ID: NCT01143883
Run by: Jorge Marcet
People needed: 110
Starts: 2009-06-01
Expected to finish: 2010-11-01
Last updated by the study team: 2013-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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