PICO- Single-use Negative Pressure Wound Therapy System

Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05064696

Enrollment

150

Registered

2021-10-01

Start date

2021-08-25

Completion date

2025-09-30

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Ankle Arthroplasty

Keywords

Total ankle arthroplasty, PICO, Ankle, Ankle joint, Arthroplasty

Brief summary

To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Detailed description

Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound. The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.

Interventions

OTHERNon-stick gauze dressing

Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing

DEVICEPICO dressing

Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Wound complications	Approximately 12-weeks after surgery (or until 3-month postop visit is completed)	To determine presence or absence of wound complications at the follow-up visits.

Countries

United States

Contacts

Primary ContactAmy Loveland

amy.loveland@medstar.net301-560-2937

Backup ContactCrisanto Macaraeg

Crisanto.L.Macaraeg@Medstar.net410-261-8218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026