Ankle DiseasePICO-PTCNCT03886818
Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty
A study testing Standard dressings and PICO strategy in people with Ankle Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Disease
- What is being tested?
- Standard dressings and PICO strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2019to 17 Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older
- Patient for whom a total ankle arthroplasty has been scheduled
- Patient affiliated to a national health insurance scheme or similar
- Patient who have signed an informed consent form for its participation in the study
Who cannot join
- Patient with contraindication to use of the PICO™ device
- Patient participating in another study including an exclusion period in progress
- Patient participating in another interventional study that may interfere with this research
- Adult patient protected by law, under guardianship or tutorship ;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie orthopédique - Groupement Hospitalier Lyon Sud
Lyon, 69310
About this study
Official title: Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.
Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.
Read more
Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO™ (Smith\&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.
To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO™ for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO™ system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.
- Conditions
- Ankle Disease
- Being tested
- Standard dressings, PICO strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dressingsDevice
Standard dressings will be used from surgery to wound healing
PICO strategyDevice
The PICO system with negatif pression will be used from surgery to day 7. After that, standard dressing will be used untill the wound Healing.
| Study group | Role | What they receive |
|---|---|---|
| PICO strategy | Experimental | * Use of PICO™ device from the ankle surgery to the post-surgery day 7.
* Use of usual care by simple dressings after post-surgery day 7 up to wound healing Receives: Device: PICO strategy |
| Standard of care | Active comparator | -Usual care by simple dressings after the ankle surgery until the wound healing. Receives: Device: Standard dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence.
Measured: Up to 12 months after TAA
Secondary outcomes (6)
Rate of technical failures of the PICO™ device, and type of failure: device failure, non-hermetic dressing, other.
Measured: baseline to postoperative day 7
Number and type of adverse effects related to the PICO™ device.
Measured: baseline to postoperative day 7
Rate of wound healing complications: presence of exudate; blister; necrosis; wound dehiscence.
Measured: postoperative day 21, postoperative week 6, postoperative months 4 and 12.
Rate of surgical site infection (superficial, deep or of a surgical site other than the incision site).
Measured: postoperative day 30 to postoperative month 12.
Rate of surgical revision for wound healing complications defined by: mechanical debridement; surgical debridement; flap surgery and skin graft.
Measured: Baseline to postoperative month 12.
Incremental Cost-Effectiveness Ratio (ICER) between the two dressing strategies.
A cost-effectiveness analysis comparing the strategy using PICO device and the one using only conventional dressing will be performed during 12 months after surgery, from the perspectives of the French hospital and French health insurance system; the result will be expressed in terms of cost per complication avoided.
Measured: Up to 12 months after TAA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Mar 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Dr BESSE, Principal investigator, Hospice Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886818
- Sponsor's protocol ID
- 69HCL18_0753
- Acronym
- PICO-PTC
- Status last verified
- Sep 2023
- First submitted
- 20 Mar 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.
- ClinicalTrials.gov ID
- NCT03886818
- Acronym / sponsor ID
- PICO-PTC / 69HCL18_0753
- Conditions
- Ankle Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 22 Mar 2019 (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.
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.
Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.
Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO™ (Smith\&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.
To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO™ for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO™ system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO strategy | Experimental | Device: PICO strategy* Use of PICO™ device from the ankle surgery to the post-surgery day 7. * Use of usual care by simple dressings after post-surgery day 7 up to wound healing |
| Standard of care | Active comparator | Device: Standard dressings-Usual care by simple dressings after the ankle surgery until the wound healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 years or older
- Patient for whom a total ankle arthroplasty has been scheduled
- Patient affiliated to a national health insurance scheme or similar
- Patient who have signed an informed consent form for its participation in the study
Key exclusion criteria (5 listed)
- Patient with contraindication to use of the PICO™ device
- Patient participating in another study including an exclusion period in progress
- Patient participating in another interventional study that may interfere with this research
- Adult patient protected by law, under guardianship or tutorship ;
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Standard dressingsStandard dressings will be used from surgery to wound healing | Device | Standard of care |
| PICO strategyThe PICO system with negatif pression will be used from surgery to day 7. After that, standard dressing will be used untill the wound Healing. | Device | PICO strategy |
Primary outcome
Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence.
Time frame: Up to 12 months after TAA
6 secondary outcomes
Rate of technical failures of the PICO™ device, and type of failure: device failure, non-hermetic dressing, other.
Time frame: baseline to postoperative day 7
Number and type of adverse effects related to the PICO™ device.
Time frame: baseline to postoperative day 7
Rate of wound healing complications: presence of exudate; blister; necrosis; wound dehiscence.
Time frame: postoperative day 21, postoperative week 6, postoperative months 4 and 12.
Rate of surgical site infection (superficial, deep or of a surgical site other than the incision site).
Time frame: postoperative day 30 to postoperative month 12.
Rate of surgical revision for wound healing complications defined by: mechanical debridement; surgical debridement; flap surgery and skin graft.
Time frame: Baseline to postoperative month 12.
Incremental Cost-Effectiveness Ratio (ICER) between the two dressing strategies.
Time frame: Up to 12 months after TAA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Luc Dr BESSE principal investigator
Hospice Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard dressings and PICO strategy in people with Ankle Disease, run by Hospices Civils de Lyon at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 28 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence. (time frame: Up to 12 months after TAA). 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 28 Sep 2023.