Total Ankle ArthroplastyNCT05064696
PICO- Single-use Negative Pressure Wound Therapy System
A study testing Non-stick gauze dressing and PICO dressing in people with Total Ankle Arthroplasty, run by Walter C Hembree at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Ankle Arthroplasty
- What is being tested?
- Non-stick gauze dressing and PICO dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Amy Loveland
Baltimore, Maryland, 21218
Amy Loveland, 301-560-2937, amy.loveland@medstar.net
Crisanto Macaraeg, 410-261-8218, Crisanto.L.Macaraeg@Medstar.net
About this study
Official title: Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.
Read the 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.
- Conditions
- Total Ankle Arthroplasty
- Being tested
- Non-stick gauze dressing, PICO dressing
- Keywords
- Total ankle arthroplasty, PICO, Ankle, Ankle joint, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-stick gauze dressingOther
Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
PICO dressingDevice
Group 2 (Treatment group): surgical site will be dressed with PICO dressing
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | Active comparator | Surgical wound will be covered with the standard non-stick gauze dressing. Receives: Other: Non-stick gauze dressing |
| Group 2 (Treatment group) | Experimental | Surgical wound will be covered with the PICO dressing. Receives: Device: PICO dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
To determine presence or absence of wound complications at the follow-up visits.
Measured: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start25 Aug 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Ankle ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter C Hembree
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor-investigator, Walter C Hembree, Medstar Health Research Institute
- Investigators
- Walter C Hembree, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064696
- Sponsor's protocol ID
- STUDY00003790
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
- ClinicalTrials.gov ID
- NCT05064696
- Acronym / sponsor ID
- STUDY00003790
- Conditions
- Total Ankle Arthroplasty
- Keywords
- Total ankle arthroplasty, PICO, Ankle, Ankle joint, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Walter C HembreeUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group) | Active comparator | Other: Non-stick gauze dressingSurgical wound will be covered with the standard non-stick gauze dressing. |
| Group 2 (Treatment group) | Experimental | Device: PICO dressingSurgical wound will be covered with the PICO dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-stick gauze dressingGroup 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing | Other | Group 1 (Control group) |
| PICO dressingGroup 2 (Treatment group): surgical site will be dressed with PICO dressing | Device | Group 2 (Treatment group) |
Primary outcome
Wound complications
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Total Ankle Arthroplasty
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A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter C Hembree, MD principal investigator
MedStar Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-stick gauze dressing and PICO dressing in people with Total Ankle Arthroplasty, run by Walter C Hembree at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Loveland (301-560-2937, amy.loveland@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound complications (time frame: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.