Status:
COMPLETED
Study Looking at the Effect of Silverlon on Post Operative Wound Infections
Lead Sponsor:
Jorge Marcet
Conditions:
Infections
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01143883
Start Date
June 1 2009
End Date
November 1 2010
Last Update
June 13 2013
Active Locations (1)
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1
Tampa General Hospital and University of South Florida Medical Clinics
Tampa, Florida, United States, 33606