PICO vs Standard Care Dressings for Preventing Surgical Site Infections

Overseen By Tiffany Morrison, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rothman Institute Orthopaedics

Must not be taking: Warfarin

Disqualifiers: Pregnancy, Skin integrity issues, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to prevent healing problems after repeat knee or hip replacement surgeries. It compares two types of dressings: a special bandage using negative pressure (gentle suction) to aid wound healing, known as Single-Use Negative Pressure Wound Therapy (PICO), and a standard surgical dressing with silver, called Aquacel Ag Surgical Dressing, to prevent infections. Individuals undergoing revision knee or hip replacements who can follow the study steps might be suitable candidates. Researchers will monitor participants for up to three months to assess incision healing. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-surgical care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on warfarin therapy, you cannot participate in the study.

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

Research has shown that the Aquacel Ag Surgical Dressing is generally safe and easy to use. In one study, patients experienced significantly less pain and anxiety during dressing changes, resulting in greater comfort and reduced need for pain medications. Another study found that these dressings reduced infection rates by 78%, suggesting they help wounds heal safely.

For the Single-Use Negative Pressure Wound Therapy (PICO), research indicates it is also safe. A review showed it helps wounds heal faster and reduces complications like wound reopening. This therapy uses gentle suction on the wound area, which can aid healing.

Both treatments have demonstrated positive safety results in previous studies, providing reassurance for anyone considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to preventing surgical site infections after surgeries like revision total joint arthroplasty. The Single-Use Negative Pressure Wound Therapy (PICO) stands out by applying continuous, gentle pressure to the wound, which can help remove excess fluid and promote healing more effectively than traditional dressings. On the other hand, the Aquacel Ag Surgical Dressing incorporates silver, an antimicrobial agent, to actively combat bacteria and reduce infection risk. These treatments are distinct from standard care options, which typically involve simple gauze or non-antimicrobial dressings, by providing enhanced protection and potentially improving recovery outcomes.

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

This trial will compare Aquacel Ag Surgical Dressing with Single-Use Negative Pressure Wound Therapy (PICO) for preventing surgical site infections. Research has shown that Aquacel Ag Surgical Dressing helps wounds heal better, reduces infections at the surgery site, and increases patient satisfaction. It also requires fewer dressing changes, enhancing patient comfort.

In contrast, Single-Use Negative Pressure Wound Therapy (PICO) has demonstrated significant reductions in infections and wound-related problems. This therapy can also shorten hospital stays, aiding recovery. Both treatments have strong evidence supporting their effectiveness in preventing complications after surgeries, and this trial will further evaluate their comparative benefits. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a second knee or hip surgery and can follow the study plan. They must not be pregnant, breastfeeding, or at risk of pregnancy without contraception. People with skin issues that prevent wound therapy use, active bleeding at the site, allergies to dressing materials, or on warfarin are excluded.

Inclusion Criteria

I am having a repeat knee or hip replacement surgery.

I understand and can follow the study's schedule and procedures.

Subjects provide informed consent after explanation of study procedures, risks, and contact information

Exclusion Criteria

My use of warfarin has led to complications and longer hospital stays after surgery.

I have wounds that need to be checked every day.

I am currently experiencing bleeding at a surgery site.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Single-Use NPWT (PICO) or standard care dressings (AQUACEL Ag Surgical Dressing) during revision TKA and THA

Immediate post-surgery period

Follow-up

Participants are monitored for incision healing complications

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Aquacel Ag Surgical Dressing
• Revision Total Joint Arthroplasty
• Single-Use Negative Pressure Wound Therapy (PICO)

Trial Overview The study compares two types of dressings to prevent infections after knee or hip revision surgeries: Single-Use Negative Pressure Wound Therapy (PICO) versus standard care dressings (AQUACEL Ag). Patients will be monitored for up to three months for healing complications.

How Is the Trial Designed?

Group I: Aquacel Ag Surgical Dressing Active Control 1 Intervention

Group II: Single-Use Negative Pressure Wound Therapy (PICO) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+

Published Research Related to This Trial

The PICO negative pressure wound therapy (NPWT) dressing was successfully used on 21 patients with various postoperative or posttraumatic wounds, demonstrating effective healing with a median treatment duration of 16 days.

Using the PICO dressing in an outpatient setting not only improved patient care by promoting faster healing but also saved hospital costs by reducing the need for inpatient stays, totaling 24 bed days saved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds. Payne, C., Edwards, D.[2022]

Patients with stoma closure wounds treated with the PICO dressing required significantly fewer visits to community nurses (1.9 visits) compared to those with traditional packing (11.9 visits), indicating improved convenience and potentially better management of the wound.

The majority of patients using the PICO dressing were able to return to work or daily activities within 1 to 2 weeks, suggesting that this negative pressure wound therapy may enhance recovery times for stoma closure wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure therapy for stoma closure sites-a nonrandomised case control study. Obeid, N., Sharma, E., Dunstan, M., et al.[2021]

The use of the PICO system for incisional negative-pressure wound therapy after lower extremity amputation (LEA) showed a lower incidence of postoperative wound complications, such as surgical site infections (SSIs) and wound dehiscence, compared to conventional dressings (12.5% vs 43.8%).

No cases of deep SSIs were reported in the PICO dressing group, indicating its potential effectiveness in enhancing wound management outcomes, despite the study's limitations of being retrospective and having a small sample size of 32 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation. Takahashi, H., Takeda, S., Tanaka, Y., et al.[2023]

In a study involving 188 moderate-risk patients undergoing laparotomy, the use of PICO dressings did not significantly reduce the rate of surgical site infections compared to standard dressings, with 14% of patients in both groups developing infections.

While there was a trend towards fewer overall surgical site complications in the PICO group (11 complications) compared to the standard dressing group (20 complications), this difference was not statistically significant, suggesting that PICO dressings may not provide a clear benefit in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Dressings (PICOTM) on Laparotomy Wounds Do Not Reduce Risk of Surgical Site Infection. Flynn, J., Choy, A., Leavy, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5558629/

AQUACEL® Ag Surgical Dressing Reduces ... The study group had longer wear time (5.2 ± 0.7 versus 1.7 ± 0.4 days, p < 0.0001) and lower number of dressing changes (1.0 ± 0.2 versus 3.6 ± 1.3 times, p < ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28831390/

AQUACEL® Ag Surgical Dressing Reduces ... The study group had longer wear time (5.2 ± 0.7 versus 1.7 ± 0.4 days, p < 0.0001) and lower number of dressing changes (1.0 ± 0.2 versus 3.6 ± 1.3 times, p < ...

3. jcpres.com jcpres.com/storage/upload/pdfs/EMJ-24482-ORIGINAL_ARTICLE-AKDOGAN.pdf

Comparison of the Aquacel Ag Surgical Dressing vs ... The results of this study showed that the Aquacel Ag surgical dress- ing significantly improved patient outcomes after TKA surgeries by decreasing ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2017/1262108

AQUACEL® Ag Surgical Dressing Reduces ... AQUACEL Ag Surgical dressing is an ideal dressing to provide wound care efficacy, patient satisfaction, reduction of SSI, and cost-effectiveness ...

5. journals.lww.com journals.lww.com/aosopen/fulltext/2024/03000/a_randomized_trial_of_ionic_silver_dressing_to.34.aspx

A Randomized Trial of Ionic Silver Dressing to Reduce... We hypothesized that Aquacel Ag Hydrofiber dressings would reduce the incidence of superficial SSIs by 50% compared to standard film dressings.

6. wjso.biomedcentral.com wjso.biomedcentral.com/articles/10.1186/1477-7819-10-94

Surgical site infections following colorectal cancer surgery Aquacel Ag Hydrofiber was associated with significantly less pain and anxiety during dressing changes, significantly fewer procedural and opiate ...

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

Comparative efficacy of advanced and traditional wound ... The primary outcomes measured were pain levels during dressing changes, exudate management, patient comfort, nurses' ease of application and removal of the ...

8. clinicaltrials.gov clinicaltrials.gov/show/NCT03180346

A Prospective, Randomized, Comparative Study to Assess ... The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated ...

9. cnbc.com cnbc.com/2012/10/01/study-finds-78-drop-in-surgical-site-infection-with-aquacel-ag-surgical-cover-dressing.html

Study Finds 78% Drop In Surgical Site Infection With ... The study found that the infection rate for total joint replacement patients dropped to 0.4 percent when AQUACEL® Ag SURGICAL cover dressing was ...