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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group 1 (Control group) 		Surgical wound will be covered with the standard non-stick gauze dressing.
  • Other: Non-stick gauze dressing
    Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
Experimental
Group 2 (Treatment group) 		Surgical wound will be covered with the PICO dressing.
  • Device: PICO dressing
    Group 2 (Treatment group): surgical site will be dressed with PICO dressing

Recruiting Locations

Amy Loveland
Baltimore, Maryland 21218
Contact:
Amy Loveland
301-560-2937
amy.loveland@medstar.net

More Details

Status
Recruiting
Sponsor
Walter C Hembree

Study Contact

Amy Loveland
301-560-2937
amy.loveland@medstar.net

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.