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 is comparing two types of dressings for patients having repeat knee or hip replacement surgeries. One dressing uses suction to help wounds heal faster, while the other uses silver to prevent infections. The goal is to see which dressing better prevents healing problems. Topical silver agents and dressings are used to control infection and promote healing in chronic wounds, but reviews have found mixed results regarding their effectiveness.

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.

Is the PICO dressing generally safe for use in humans?

The PICO dressing has been used safely in various studies for different types of wounds, including surgical and traumatic wounds, without significant safety concerns. It has been shown to reduce complications like infections and wound dehiscence (wound reopening) in some cases, although its effectiveness can vary depending on the specific condition and patient group. ^{1 2 3 4 5}

How does the PICO treatment differ from standard care for preventing surgical site infections?

The PICO treatment is unique because it uses a single-use negative pressure wound therapy system, which helps to reduce wound complications by applying gentle suction to the wound area, promoting faster healing and reducing the risk of infection. This is different from standard care dressings, which do not use negative pressure and may require more frequent changes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Aquacel Ag Surgical Dressing and PICO for preventing surgical site infections?

Research shows that the Aquacel Ag Surgical Dressing significantly reduces the rate of surgical site infections (SSIs) and improves patient satisfaction after surgeries like total knee arthroplasty. Additionally, the PICO system, a type of negative pressure wound therapy, has been effective in reducing wound complications, including infections, in various surgical and traumatic wounds. ^{1 3 4 6 7}

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]

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]

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]

Citations

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

The effectiveness of prophylactic closed incision negative pressure wound therapy compared to conventional dressings in the prevention of periprosthetic joint infection post hip and knee revision arthroplasty surgery: A systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

AQUACEL® Ag Surgical Dressing Reduces Surgical Site Infection and Improves Patient Satisfaction in Minimally Invasive Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. [2018]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Aquacel surgical dressing reduces the rate of acute PJI following total joint arthroplasty: a case-control study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Negative Pressure Dressings (PICOTM) on Laparotomy Wounds Do Not Reduce Risk of Surgical Site Infection. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Negative pressure therapy for stoma closure sites-a nonrandomised case control study. [2021]