What side effects are associated with this type of intervention?

Common side effects of Single-Use Negative Pressure Wound Therapy (NPWT) like PICO include skin irritation, pain at the wound site, and potential for infection if the device is not properly maintained. Issues with the seal of the dressing can also occur, leading to ineffective therapy. In rare cases, patients may experience bleeding or damage to underlying tissues. These side effects are generally manageable with proper use and monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Surgical Site Infections (SSIs), including various forms of Negative Pressure Wound Therapy (NPWT). One notable example is the V.A.C.® Therapy System, which uses controlled negative pressure to help promote wound healing and manage infections. Similar to the PICO system being studied, these NPWT devices are designed to reduce the risk of complications by maintaining a moist wound environment and removing exudate. Other related FDA-approved treatments include antimicrobial dressings like AQUACEL® Ag, which incorporate silver to provide broad-spectrum antimicrobial activity, further aiding in the prevention and management of SSIs.

What other types of research exist?

Promising novel alternatives to Single-Use NPWT (PICO) for preventing SSIs include: 1) Standard care dressings like AQUACEL® Ag Surgical Dressing, which incorporates antimicrobial properties to reduce infection risk. 2) Topical nitroglycerin, which may improve wound healing by stimulating collagen synthesis. 3) Ultrasound-guided percutaneous needle tenotomy, which can break up calcifications and promote healing. 4) Advanced dressings such as hyperoxygenated fatty acid compounds and five-layered soft silicone foam dressings, which have shown efficacy in preventing pressure ulcers and may be beneficial for SSIs. These alternatives should be discussed with a healthcare provider to determine the best option based on individual patient needs and wound characteristics.

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PICO vs Standard Care Dressings for Preventing Surgical Site Infections

N/A

Waitlist Available

Research Sponsored by Rothman Institute Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty

Patient must be ≥18 years old

Must not have

Wounds that require daily inspection

Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include skin irritation from adhesives in both PICO and AQUACEL Ag dressings. There's also a potential risk of delayed healing if there's an allergic reaction to dressing components like silicone adhesives and super-absorbent powders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a repeat knee or hip replacement surgery.

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I am 18 years old or older.

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I am a man, or I am a woman who is not pregnant, not breastfeeding, and either postmenopausal or have had surgery to prevent pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have wounds that need to be checked every day.

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I cannot use vacuum-assisted wound care due to skin problems.

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I am having my first major joint surgery.

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I am currently experiencing bleeding at a surgery site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Aquacel Ag Surgical DressingActive Control1 Intervention

Group II: Single-Use Negative Pressure Wound Therapy (PICO)Active Control1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Single-Use Negative Pressure Wound Therapy (NPWT) applies continuous or intermittent negative pressure to the wound, which helps to remove exudate and infectious materials, reduce edema, and promote blood flow to the area. This environment supports faster wound healing and reduces the risk of complications such as infection. For Surgical Site Infection (SSI) patients, understanding these mechanisms is crucial as effective management of the wound environment can significantly improve healing outcomes and reduce the incidence of postoperative complications.

What is the effectiveness of the negative pressure wound therapy (NPWT) in patients treated with open abdomen technique? A systematic review and meta-analysis.The challenges of managing a complex stoma with NPWT.