Infections, Surgery
Conditions
Keywords
All patients undergoing a colorectal resection, surgical site infections
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
Interventions
OTHERSilverlon
Silverlon dressings are gauze impregnated with silver ions
Standard dry gauze dressing
Sponsors
Jorge Marcet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
All 110 patients were consented for this study during their pre-operative visit.
Participants by arm
| Arm | Count |
|---|---|
| Silverlon Dressing 55 | 55 |
| Standard of Care Dressing 55 | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Standard of Care Dressing | Silverlon Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 48 Participants | 10 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 45 Participants | 49 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 11.1 | 62 years STANDARD_DEVIATION 15.6 | 60 years STANDARD_DEVIATION 13.7 |
| Gender Female | 28 participants | 27 participants | 55 participants |
| Gender Male | 26 participants | 28 participants | 54 participants |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
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.
Time frame: Day of surgery up to 30 days post operatively
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Silverlon Dressing | Surgical Site Infection | 13 percentage of participants with SSI |
| Standard of Care Dressing | Surgical Site Infection | 33 percentage of participants with SSI |