HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Stanford University · Updated on 2022-10-26
660
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are evaluating two alternative sternal dressings compared to the standard Island dressing to reduce surgical site infection rates in patients undergoing cardiac surgery with a sternotomy incision. The study aims to identify which dressing leads to the lowest rate of sternal wound infection and also examines the impact of these dressings on hospital readmission rates related to infections within 30 days after surgery. Participants will be randomly assigned to receive one of three dressings applied immediately after their cardiovascular surgery the standard Island dressing, the Prevena negative pressure wound suction dressing, or the Mepilex Border Post-Op Ag dressing impregnated with silver ions. The standard dressing is removed 48 hours after surgery, while the Prevena and Mepilex dressings remain in place for up to 7 days or until patient discharge if earlier. During the study, participants will be monitored for surgical site infections from the day of surgery up to 7 days post-operation or until discharge, whichever comes first. Researchers will also track infection rates at the sternal incision site and related hospital readmissions up to 30 days after discharge. The study involves follow-up assessments to evaluate the safety and effectiveness of each dressing over time.
CONDITIONS
Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
J
Jack Boyd, M.D.
C
Clarivil Cruz Gonzales, RN
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Stanford University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Standard Island Dressing | Prevena Negative Pressure Wound Dressing | Mepilex Border Post-Op Ag |
|---|---|---|---|
| What it is | A traditional sterile gauze pad with adhesive border, applied to the sternal incision after cardiac surgery. | A negative pressure wound therapy dressing system, designed to apply continuous suction over the closed sternal incision. | A specialized foam dressing containing silver, placed over the sternal incision to reduce infection risk. |
| Role in trial | Serves as the standard control dressing arm. | An investigational alternative dressing assigned by randomization to compare infection rates. | Another alternative dressing assigned by randomization, also studied for its effects on infection rates. |
| Primary use in patient care | Standard method for covering sternal incisions to protect the wound and absorb drainage. | An alternative dressing designed to apply negative pressure, aiming to lower the risk of surgical site infection after sternotomy. | A silver-impregnated post-op foam dressing thought to reduce infection risk by providing antimicrobial protection for the surgical wound. |
| How it is applied | Placed directly over the closed sternal incision at the end of surgery and left in place per standard protocol. | Applied in the operating room before wound closure is complete, connected to a negative pressure device, and left in place to provide continuous suction. | Applied after wound closure at the conclusion of surgery, providing a secure dressing with antimicrobial properties. |
| Evidence status | Well established as routine care for sternal incision coverage, but not proven to lower infection rates beyond basic wound protection. | Early studies and clinical experience suggest negative pressure dressings may help lower surgical site infection rates after high-risk incisions, but evidence is still being established. | Antimicrobial silver foam dressings are suggested to reduce surgical site infections, though robust head-to-head trial evidence is limited. |
| Important limitations | Does not provide active antimicrobial effect or additional infection prevention beyond passive wound protection. | May require special training and device connection; increased cost compared to standard dressings; additional evidence is needed. | Added cost and variable availability; insufficient evidence from large trials about its comparative effectiveness in this setting. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus up to 7 days post-operative
Participants undergo cardiovascular surgery with a sternotomy incision, and a randomized dressing is applied immediately after surgery in the operating room.
Dressing removal visit 48 hours after surgery for Standard Island Dressing; dressing remains up to 7 days or until discharge for other dressings
Duration - Up to 30 days after discharge
Participants are monitored for surgical site infections and healing after discharge, up to 30 days post-discharge.
Follow-up visits as scheduled for wound assessment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Candis Lee Kles, C Patrick Murrah, Kerry Smith...
https://pubmed.ncbi.nlm.nih.gov/26244240/Sue Barnes
https://pubmed.ncbi.nlm.nih.gov/26219113/Stanford University
Lead Sponsor
