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

• Sponsor: Jorge Marcet (Other)
• Overall Status: Completed
• CT.gov ID: NCT01143883
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infections; Surgery	Other: Silverlon; Other: Standard of Care Dressing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silverlon Dressing The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.	Other: Silverlon; Silverlon dressings are gauze impregnated with silver ions
Active Comparator: Standard of Care Dressing The standard plain gauze is used to dress the wound postoperatively	Other: Standard of Care Dressing; Standard dry gauze dressing

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital and University of South Florida Medical Clinics	Tampa	Florida	United States	33606

Sponsors and Collaborators

• Jorge Marcet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jorge Marcet, Professor, Department of Surgery, University of South Florida
• ClinicalTrials.gov Identifier: NCT01143883
• Other Study ID Numbers: Silverlon 108010
• First Posted: Jun 14, 2010
• Last Update Posted: Jun 13, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Jorge Marcet, Professor, Department of Surgery, University of South Florida: All patients undergoing a colorectal resection; surgical site infections
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

Participant Flow

Recruitment Details	All 110 patients were consented for this study during their pre-operative visit.

Arm/Group Title	Silverlon Dressing	Standard of Care Dressing
Arm/Group Description	The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.	The standard plain gauze is used to dress the wound postoperatively
Period Title: Overall Study
STARTED	55	55
COMPLETED	55	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Silverlon Dressing	Standard of Care Dressing	Total
Arm/Group Description	55	55	Total of all reporting groups
Overall Participants	55	55	110
Age (Count of Participants)
<=18 years	0 0%	3 5.5%	3 2.7%
Between 18 and 65 years	45 81.8%	4 7.3%	49 44.5%
>=65 years	10 18.2%	48 87.3%	58 52.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (15.6)	58 (11.1)	60 (13.7)
Gender (participants) [Number]
Female	27 49.1%	28 50.9%	55 50%
Male	28 50.9%	26 47.3%	54 49.1%
Region of Enrollment (participants) [Number]
United States	55 100%	55 100%	110 100%

Outcome Measures

1. Primary Outcome

Title	Surgical Site Infection
Description	We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.
Time Frame	Day of surgery up to 30 days post operatively

Outcome Measure Data

Analysis Population Description

The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol

Arm/Group Title	Silverlon Dressing	Standard of Care Dressing
Arm/Group Description	55	55
Measure Participants	55	54
Number [percentage of participants with SSI]	13 23.6%	33 60%

Adverse Events

Arm/Group Title	Silverlon Dressing		Standard of Care Dressing
Arm/Group Description	55		55
All Cause Mortality
	Silverlon Dressing		Standard of Care Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Silverlon Dressing		Standard of Care Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Silverlon Dressing		Standard of Care Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/55 (1.8%)		0/55 (0%)
Skin and subcutaneous tissue disorders
Rash	1/55 (1.8%)		0/55 (0%)

Limitations/Caveats

Members of the surgical team were not blinded to the treatment group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.