PICO- Single-use Negative Pressure Wound Therapy System

Launched by WALTER C HEMBREE · Sep 30, 2021

Keywords

ClinConnect Summary

The PICO trial is studying a new type of wound dressing called the PICO dressing to see if it helps prevent complications after total ankle replacement surgery. This surgery, known as total ankle arthroplasty, involves replacing damaged parts of the ankle with artificial ones. The researchers want to compare how well the PICO dressing works compared to a standard nonstick gauze dressing in keeping the surgical site healthy and free from infections or other issues.

To participate in this study, you need to be at least 18 years old and scheduled for total ankle arthroplasty or a straightforward revision of the surgery. It's important that you can understand the study and follow the visit schedule. Unfortunately, people with a history of serious infections or wound problems, allergies to the study materials, pregnant or breastfeeding women, and those who may not follow medical advice are not eligible. If you join the study, you can expect regular check-ins and assessments to monitor your recovery and the effectiveness of the dressings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥18 years old
• • Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
• • Subjects able to provide informed consent
• • Subjects who are able to understand and comply with study visit schedule and procedures
• Exclusion Criteria:
• • History of previous deep infection or history of wound complication necessitating plastic surgery intervention
• • Allergy to products used in the study
• • Pregnant and breastfeeding women due to anesthesia risks
• • Subjects with a known history of poor compliance with medical treatment
• • Subjects who decline participation in this research study
• • Prisoners