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

Not Applicable

Completed

Conditions: Infections
Surgery

Interventions: Other: Silverlon
Other: Standard of Care Dressing

Registration Number: NCT01143883

Lead Sponsor: Jorge Marcet

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silverlon Dressing	Silverlon	The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
Standard of Care Dressing	Standard of Care Dressing	The standard plain gauze is used to dress the wound postoperatively

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	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.

Secondary Outcome Measures