Clinical trial NCT01143883: Study Looking at the Effect of Silverlon on Post Operative Wound Infections
Official title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Surgery
Keywords: All patients undergoing a colorectal resection
surgical site infections
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: Day of surgery up to 30 days post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital and University of South Florida Medical Clinics
state: Florida
Study officials:
References:
citation: 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.