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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital and University of South Florida Medical Clinics

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Silverlon

Other

Silverlon dressings are gauze impregnated with silver ions

Standard of Care Dressing

Other

Standard dry gauze dressing

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Jorge Marcet

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jun 14, 2010
Registry last updated: Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed