InfectionsNCT01143883
Study Looking at the Effect of Silverlon on Post Operative Wound Infections
A study testing Silverlon in people with Infections and Surgery, run by Jorge Marcet at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Surgery
- What is being tested?
- Silverlon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital and University of South Florida Medical Clinics
Tampa, Florida, 33606
About this study
Official title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
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
- Conditions
- Infections, Surgery
- Being tested
- Silverlon, Standard of Care Dressing
- Keywords
- All patients undergoing a colorectal resection, surgical site infections
- Medical subject headings
- Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverlonOther
Silverlon dressings are gauze impregnated with silver ions
Standard of Care DressingOther
Standard dry gauze dressing
| Study group | Role | What they receive |
|---|---|---|
| Silverlon Dressing | Experimental | The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon. Receives: Other: Silverlon |
| Standard of Care Dressing | Active comparator | The standard plain gauze is used to dress the wound postoperatively Receives: Other: Standard of Care Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery up to 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorge Marcet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Marcet, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143883
- Sponsor's protocol ID
- Silverlon 108010
- Status last verified
- Jun 2013
- First submitted
- 24 Mar 2010
- Last updated
- 13 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21730792
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01143883
- Acronym / sponsor ID
- Silverlon 108010
- Conditions
- Infections, Surgery
- Keywords
- All patients undergoing a colorectal resection, surgical site infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jorge MarcetUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 13 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silverlon Dressing | Experimental | Other: SilverlonThe 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 | Other: Standard of Care DressingThe standard plain gauze is used to dress the wound postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilverlonSilverlon dressings are gauze impregnated with silver ions | Other | Silverlon Dressing |
| Standard of Care DressingStandard dry gauze dressing | Other | Standard of Care Dressing |
Primary outcome
Surgical Site Infection
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21730792Krieger 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silverlon in people with Infections and Surgery, run by Jorge Marcet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: Day of surgery up to 30 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.