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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
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 belowSelect...
I am having a repeat knee or hip replacement surgery.
Select...
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:Select...
I have wounds that need to be checked every day.
Select...
I cannot use vacuum-assisted wound care due to skin problems.
Select...
I am having my first major joint surgery.
Select...
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
Treatment Details
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
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.
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.
Find a Location
Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
126 Previous Clinical Trials
22,584 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a repeat knee or hip replacement surgery.My use of warfarin has led to complications and longer hospital stays after surgery.I understand and can follow the study's schedule and procedures.I have wounds that need to be checked every day.I am currently experiencing bleeding at a surgery site.I cannot use vacuum-assisted wound care due to skin problems.I am having my first major joint surgery.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.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Aquacel Ag Surgical Dressing
- Group 2: Single-Use Negative Pressure Wound Therapy (PICO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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