Wound InfectionNCT01169064
Topical Silver for Prevention of Wound Infection After Cesarean Delivery
A study testing Silver-containing surgical dressing and Cloth adhesive dressing in people with Wound Infection, run by Vanderbilt University at 1 site in United States.
Trial summary
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Wound Infection
- What is being tested?
- Silver-containing surgical dressing and Cloth adhesive dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2012
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cesarean delivery with pfannenstiel incision
Who cannot join
- Incision other than pfannenstiel
- Silver allergy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Hospital
Nashville, Tennessee, 37232
About this study
Official title: Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.
- Conditions
- Wound Infection
- Being tested
- Silver-containing surgical dressing, Cloth adhesive dressing
- Keywords
- Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver-containing surgical dressingDevice
Also called Acticoat
Dressing placed over surgical incision and remain for 3-5 days
Cloth adhesive dressingDevice
Also called Medipore
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
| Study group | Role | What they receive |
|---|---|---|
| Silver-containing surgical dressing | Active comparator | Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver Receives: Device: Silver-containing surgical dressing |
| Cloth adhesive dressing | Active comparator | Soft cloth adhesive wound dressing Receives: Device: Cloth adhesive dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silver Treatment Efficacy
As measured by number of patients with postop infections at 6 wks
Measured: 6 weeks postpartum
Secondary outcomes (2)
Infection Rate Adjusted for Maternal BMI
Measured: 6 weeks postpartum
Patient Dressing Cost
Total cost of dressings per group based on 1 dressing per patient
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Interim analysis showed no statistical significance achieved.
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.
- Other trials for Wound InfectionStudies 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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Bennett, Vanderbilt University
- Investigators
- Kelly A. Bennett, MD, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169064
- Sponsor's protocol ID
- VUMFM-100785
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2010
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01169064
- Acronym / sponsor ID
- VUMFM-100785
- Conditions
- Wound Infection
- Keywords
- Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed no statistical significance achieved.
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver-containing surgical dressing | Active comparator | Device: Silver-containing surgical dressingSelf adhesive 4 x 10 dressing impregnated with nanocrystalline silver |
| Cloth adhesive dressing | Active comparator | Device: Cloth adhesive dressingSoft cloth adhesive wound dressing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cesarean delivery with pfannenstiel incision
Key exclusion criteria (3 listed)
- Incision other than pfannenstiel
- Silver allergy
- Inability to provide informed consent
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 |
|---|---|---|
| Silver-containing surgical dressingAlso: ActicoatDressing placed over surgical incision and remain for 3-5 days | Device | Silver-containing surgical dressing |
| Cloth adhesive dressingAlso: MediporeCloth adhesive dressing placed over surgical incision and remains for 3-5 days | Device | Cloth adhesive dressing |
Primary outcome
Silver Treatment Efficacy
Time frame: 6 weeks postpartum
As measured by number of patients with postop infections at 6 wks
2 secondary outcomes
Infection Rate Adjusted for Maternal BMI
Time frame: 6 weeks postpartum
Patient Dressing Cost
Time frame: Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kelly A. Bennett, MD principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver-containing surgical dressing and Cloth adhesive dressing in people with Wound Infection, run by Vanderbilt University 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 May 2017. 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 30 May 2017). 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?
Silver Treatment Efficacy (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.