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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silverlon Dressing | Experimental | 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 | Active Comparator | The standard plain gauze is used to dress the wound postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silverlon | Other | Silverlon dressings are gauze impregnated with silver ions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection | We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics. | Day of surgery up to 30 days post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital and University of South Florida Medical Clinics | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21730792 | Derived | 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. |
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All 110 patients were consented for this study during their pre-operative visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silverlon Dressing | The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon. |
| FG001 | Standard of Care Dressing | The standard plain gauze is used to dress the wound postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silverlon Dressing | 55 |
| BG001 | Standard of Care Dressing | 55 |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgical Site Infection | We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics. | 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 | Posted | Number | percentage of participants with SSI | Day of surgery up to 30 days post operatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silverlon Dressing | 55 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Rash resolved after dressing removed |
Members of the surgical team were not blinded to the treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge E. Marcet, M.D. | University of South Florida | 813-844-4545 | jmateka@health.usf.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C500574 | silverlon |
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| Standard of Care Dressing |
| Other |
Standard dry gauze dressing |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 55 |
| 1 |
| 55 |
| EG001 | Standard of Care Dressing | 55 | 0 | 55 | 0 | 55 |
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