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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of dressings to determine which best prevents infections in the chest area after heart surgery. Researchers will assign participants to one of three groups, each using a different dressing on their surgical incision, to identify which dressing most effectively reduces infection risk. The study will also examine whether these dressings impact the rate of hospital readmissions within 30 days due to infections. Individuals undergoing heart surgery involving a sternotomy, such as valve replacements or bypass surgeries, may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance post-surgical care for future patients.

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 prior data suggests that these alternative dressings are safe for surgical site infections?

Research has shown that Mepilex Border Post-Op Ag dressings are generally easy for patients to use. These dressings can help reduce problems at the surgical site and increase patient comfort. They also effectively prevent infections. Most patients in studies experienced only minor issues, such as skin redness or itching.

For the Prevena negative pressure wound dressing, research has found it effective for surgical wounds. This dressing uses a special suction system to aid healing and reduce infection risk. In studies, patients using this dressing experienced fewer infections compared to those using regular dressings.

Both dressings have been safely used in many studies, demonstrating they are well-tolerated for managing surgical wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these alternative dressings for surgical site infections because they offer unique features compared to standard care options. Unlike the typical dressings that are removed after 48 hours, the Mepilex Border Post-Op Ag dressing is impregnated with silver ions, which are known for their antimicrobial properties, and can stay on for up to 7 days. This could potentially reduce the risk of infection over a longer period. The Prevena negative pressure dressing, on the other hand, uses a suction machine to remove fluids and promote healing, which might accelerate recovery. These innovative approaches could lead to improved outcomes for patients undergoing cardiovascular surgery.

What evidence suggests that this trial's dressings could be effective for reducing surgical site infections?

This trial will compare different dressings for surgical site infections. Studies have shown that the Mepilex Border Post-Op Ag dressing, one of the dressings tested in this trial, can greatly reduce problems at the surgery site. This dressing uses silver to kill bacteria and help prevent infections. Patients using this dressing have reported feeling more comfortable and needing fewer dressing changes. Another dressing tested in this trial is the Prevena negative pressure wound dressing. Research shows that it effectively uses gentle suction to remove extra fluid and keep the wound dry, which can lower the risk of infection. Studies confirm that this method significantly reduces the chance of infection at the surgical site. ^{1 2 5 6 7}

Who Is on the Research Team?

Jack Boyd, M.D.

Principal Investigator

Cardiovascular Surgeon

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566225000293

Comparative efficacy of advanced and traditional wound ... Multivariate analysis confirmed that Mepilex Border Post-Op® significantly reduced surgical site complications and improved patient comfort, with adjusted odds ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4367919/

Clinical trial to evaluate the performance of a flexible self ... Mepilex® Border Post-Op is a highly conformable self-adherent dressing that absorbs blood exudates and should minimize the risk of maceration.

3. molnlycke.us molnlycke.us/products-solutions/mepilex-border-post-op-ag/

Mepilex Border Post-Op Ag all-in-one silver post-op dressing Helps reduce surgical site infections · Support patient mobility · Reduce dressing related costs · Provides a broad and sustained antimicrobial effect · minimizes ...

4. nature.com nature.com/articles/s41598-025-02533-7

A prospective randomized study that compares three ... Mepilex dressings were changed less frequently than with the use of conventional dressings but no significant differences were found in SSI32. ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02653183

Prospective, Randomized Clinical Investigation of Two ... Device : Experimental: Mepilex Border Post-Op. Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment: Total 5 days included ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878124118301187

Mepilex® Border Post-Op versus Aquacel® surgical Mepilex Border Post-Op was comparable or superior to Aquacel® Surgical in all parameters investigated. Dressing failure rates, skin redness, itching under ...

7. molnlycke.us molnlycke.us/our-knowledge/trial-comparing-two-wound-dressings-after-elective-hip-knee-arthroplasty/

Study: A randomized controlled trial comparing two wound ... Both dressings performed well in terms of minimising post-operative wound complications. However, clinicians found Mepilex Border Post-Op to be superior.