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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post-op

Awards & highlights

Study Summary

This trial is testing if a new kind of wound dressing helps prevent complications in people getting revision hip or knee surgery.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Surgical Site Infection

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor

121 Previous Clinical Trials

21,578 Total Patients Enrolled

Media Library

Aquacel Ag Surgical Dressing Clinical Trial Eligibility Overview. Trial Name: NCT02664168 — N/A

Surgical Site Infection Research Study Groups: Aquacel Ag Surgical Dressing, Single-Use Negative Pressure Wound Therapy (PICO)

Surgical Site Infection Clinical Trial 2023: Aquacel Ag Surgical Dressing Highlights & Side Effects. Trial Name: NCT02664168 — N/A

Aquacel Ag Surgical Dressing 2023 Treatment Timeline for Medical Study. Trial Name: NCT02664168 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots within this medical research for volunteers?

"Presently, this clinical research study is not recruiting volunteers. Initially posted on January 1st 2016 and last altered on April 10th 2018, no new participants are required for the time being. That said, there are other studies with open recruitment; 1572 medical trials have immediate participant requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)

2016. "A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02664168.

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