PICO vs Standard Care Dressings for Preventing Surgical Site Infections

TM
Overseen ByTiffany Morrison, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rothman Institute Orthopaedics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.34567

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.34567

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.

Eligibility Criteria

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
See 1 more

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: Aquacel Ag Surgical DressingActive Control1 Intervention
Group II: Single-Use Negative Pressure Wound Therapy (PICO)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials
127
Recruited
22,600+

Findings from Research

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

References

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]
AQUACEL® Ag Surgical Dressing Reduces Surgical Site Infection and Improves Patient Satisfaction in Minimally Invasive Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. [2018]
Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds. [2022]
Aquacel surgical dressing reduces the rate of acute PJI following total joint arthroplasty: a case-control study. [2022]
Effectiveness of Specific Single-Use Incisional Negative Pressure Wound Therapy (PICO System) After Major Lower Extremity Amputation. [2023]
Negative Pressure Dressings (PICOTM) on Laparotomy Wounds Do Not Reduce Risk of Surgical Site Infection. [2021]
Negative pressure therapy for stoma closure sites-a nonrandomised case control study. [2021]
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