Alternative Dressings for Surgical Site Infections

Overseen By Clarivil Cruz Gonzales, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Heart transplants, VAD, tamponade, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 7 days

660 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Mepilex Border Post-Op Ag, Prevena Negative Pressure Wound Dressing, and Standard Island Dressing for surgical site infections?

Research shows that different dressing strategies, including foam island dressings and negative pressure wound dressings, can influence the risk of surgical site infections. These dressings are evaluated for their ability to reduce infection rates, pain, and improve scar appearance, suggesting potential benefits in managing surgical wounds. ^{1 2 3 4 5}

How does the Standard Island Dressing treatment differ from other treatments for surgical site infections?

Standard Island Dressing is a type of wound dressing used to prevent surgical site infections by covering the wound to protect it from bacteria and other contaminants. Unlike some traditional dressings, it may be designed to maintain a moist environment, which can promote faster healing and reduce the risk of infection. ^{2 6 7 8 9}

What is the purpose of this trial?

This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.

Research Team

Jack Boyd, M.D.

Principal Investigator

Cardiovascular Surgeon

Eligibility Criteria

This trial is for cardiac surgery patients at Stanford Hospital who will have a sternotomy incision. It's open to those having valve surgeries, CABGs, and several other specific heart procedures. However, it excludes heart transplant recipients, patients with Ventricular Assist Devices (VAD), or complications like tamponade or open chest after surgery.

Inclusion Criteria

I am scheduled for heart surgery that involves opening my chest.

I have had heart surgery, such as valve replacement or bypass.

Exclusion Criteria

I had complications after surgery that required additional operations.

I had complications from surgery, specifically fluid buildup around my heart.

My chest was opened during surgery and I had complications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of three dressings applied to the sternotomy wound incision immediately after cardiovascular surgery

7 days

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infection rates and hospital readmission related to SSI

30 days

1 visit (in-person), additional follow-up as needed

Treatment Details

Interventions

• Mepilex Border Post-Op Ag
• Prevena Negative Pressure wound dressing
• Standard Island Dressing

Trial Overview The study compares two alternative dressings—Mepilex Border Post-Op Ag and Prevena Negative Pressure—with the standard Island dressing to see which reduces surgical site infection rates post-cardiac surgery. The impact on hospital readmission rates within 30 days due to infections is also being assessed.

Participant Groups

Group I: Dressing 1: Standard Island Dressing Active Control 1 Intervention

Standard dressing that is applied on most patients with a sternotomy wound incision immediately after cardiovascular surgery before leaving the operating room. Dressing will be removed 48 hours after surgery.

Group II: Dressing 3: Mepilex Border Post-Op Ag Active Control 1 Intervention

Mepilex Border PostOp AG dressing impregnated with silver ions. Dressing will be in use for 7 days or removed earlier if patient is discharged before end of 7 days post0operative time period.

Group III: Dressing 2: Prevena negative pressure Active Control 1 Intervention

Prevena negative pressure wound suction machine dressing applied to sternotomy wound incision immediately after cardiovascular surgery. Dressing will be in use for 7 days or removed sooner if participant is discharged before end of 7 day post-operative time period.

Standard Island Dressing is already approved in United States for the following indications:

Approved in United States as Standard Island Dressing for:

• Post-surgical wound care
• Sternal wound dressing

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The new post-operative foam island dressing was evaluated in 14 female patients undergoing elective gynaecological surgery, showing excellent performance with 100% of clinicians rating it effective in preventing blisters and 86% rating its shower-proof capabilities as good.

No wound infections or adverse events were reported, highlighting the dressing's safety and effectiveness in maintaining skin integrity and patient comfort during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance and ease of use evaluation of a new surgical post-operative foam island dressing in 14 patients undergoing elective gynaecological surgery. Gibson, E., Stephens, C.[2014]

A systematic review of 16 randomized controlled trials involving 2594 participants found no significant difference in surgical-site infection rates between various wound dressings and wounds left uncovered.

Additionally, there were no notable differences in pain, scarring, or acceptability among the different dressings, indicating that the choice of dressing may not impact these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of wound dressings in the prevention of surgical-site infections in surgical wounds healing by primary intention. Walter, CJ., Dumville, JC., Sharp, CA., et al.[2018]

The Bluebelle study successfully randomized 394 patients undergoing abdominal surgery to evaluate different dressing strategies, including 'simple dressing', 'glue-as-a-dressing', and 'no dressing', with a low non-adherence rate to treatment allocations.

The overall surgical site infection (SSI) rate was found to be 18.1%, indicating a significant prevalence of SSI in primary surgical wounds, which highlights the importance of further research into effective dressing strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds. Blazeby, J.[2021]

Strict adherence to prophylactic antibiotic guidelines is crucial for reducing the risk of surgical site infections, which are common and can lead to complications like prolonged recovery and increased healthcare costs.

Monitoring patients' oxygenation status and body temperature, along with diligent follow-up of surgical wounds after discharge, can significantly enhance the prevention of surgical site infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving issues in the prevention of surgical site infections. Quinn, A., Hill, AD., Humphreys, H.[2019]

Surgical site infections in orthopedic implant surgeries can lead to longer hospital stays, higher readmission rates, increased costs, and greater mortality risk, highlighting the importance of prevention strategies.

The recommendations focus on improving compliance with safety practices throughout all phases of surgery and optimizing antibiotic use before, during, and after the procedure to reduce the risk of infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recommendations for prevention of surgical site infection in adult elective arthroplasty]. Chuluyán, JC., Vila, A., Chattás, AL., et al.[2018]

Burn wounds have unique characteristics that differentiate them from other skin injuries, which necessitates specialized treatment approaches.

The paper reviews various types of burn dressings and compares their effectiveness against the ideal dressing criteria, highlighting the ongoing need for improved biomaterials in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of burn dressings. Quinn, KJ., Courtney, JM., Evans, JH., et al.[2019]

In a study involving 120 patients with superficial partial-thickness burn wounds, carbon fiber dressing demonstrated the highest water absorption rate (988%) and the lowest evaporation rate from the burn surface, indicating its superior performance in wound management.

Compared to traditional vaseline gauze, the new dressings (carbon fiber, silver nanoparticle, and hydrogel) significantly reduced evaporation from wounds, which is crucial for maintaining a moist healing environment and promoting faster recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the absorbency of four dressings and their effects on the evaporation of burn wounds. Chen, J., Han, CM., Su, GL., et al.[2017]

Modern wound dressings, which support the principle of moist wound healing, are more effective than conventional methods in promoting the healing of chronic wounds, as they are tailored to different phases of wound healing.

The use of advanced materials like polyurethane foams, alginates, and biological skin equivalents can significantly enhance wound closure and reduce complications, with ongoing studies exploring the potential of cytokines and new skin substitutes for further improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Differentiated local therapy of chronic wounds with modern wound dressings]. Eich, D., Stadler, R.[2012]

This pilot trial is exploring the feasibility of comparing different wound dressing methods (simple dressings, no dressing, and tissue-glue) in preventing surgical site infections (SSIs) in adults undergoing abdominal surgery, with a focus on participant acceptability and recruitment.

Early results indicate that recruitment is going well and that participants find the interventions acceptable, which will help shape the design of a larger, definitive trial to assess the effectiveness of these dressing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial. Reeves, BC., Andronis, L., Blazeby, JM., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Performance and ease of use evaluation of a new surgical post-operative foam island dressing in 14 patients undergoing elective gynaecological surgery. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of wound dressings in the prevention of surgical-site infections in surgical wounds healing by primary intention. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds. [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

Evolving issues in the prevention of surgical site infections. [2019]

5. Argentina pubmed.ncbi.nlm.nih.gov

[Recommendations for prevention of surgical site infection in adult elective arthroplasty]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Principles of burn dressings. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the absorbency of four dressings and their effects on the evaporation of burn wounds. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Differentiated local therapy of chronic wounds with modern wound dressings]. [2012]

9. England pubmed.ncbi.nlm.nih.gov

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial. [2023]