Ankle InjuriesTACNCT04209582
Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
An observational study of Ankle Injuries, run by Nantes University Hospital at 1 site in France.
Trial summary
This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- measurement of TcPO2 with skin electrode
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 9 Jul 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The population studied concerns all adult patients suffering from ankle trauma requiring surgical management, it is heterogeneous, concerns all ages, regardless of co-morbidities. Minor patients and patients unable to give their consent will not be included.
Who may be able to join
- Patients with surgery of ankle trauma
Who cannot join
- Patient who does not agree to participate
- Patient unable to express agreement (ex: unconscious)
- Minor patient
- Major patient under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.
Read the detailed description
This prospective observational study aims to determine the limit of TcPO2 predictive of postoperative cutaneous pain in patients with ankle trauma.
A TcPO2 measurement will be performed preoperatively at the patient's arrival in the emergency room, then every day after the operation for 3 days and finally at the follow-up visits at 3 and 6 weeks.
The cutaneous pain is evaluated by a PSAS self-questionnaire (completed by the patient) and an OSAS questionnaire (completed by the surgeon). These grids evaluate the tolerance and cicatricial quality in the medium and long term by the operator and the patient.
- Conditions
- Ankle Injuries
- Being tested
- measurement of TcPO2 with skin electrode
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of TcPO2 with skin electrodeDevice
measurement of TcPO2 with skin electrode
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of postoperative skin pain within 3 months postoperatively
Measured: 0-3 Month
Secondary outcomes (10)
Preoperative TcPO2 on the injured ankle and contralateral ankle
compare TcPO2 values between healthy ankle and traumatized ankle
Measured: day 0
Preoperative and postoperative day 1 TcPO2 on the injured ankle
Compare TcPO2 values before and after surgery
Measured: Day 1
Rates of postoperative complications related to S12 surgery and TcPO2 measurements
Measure surgical complications based on TcPo2 measurements
Measured: 3 months
Surgical revision rate at S12 and TcPO2 measurements
Measure the number of surgical revisions based on TcPo2 measurements
Measured: 3 months
Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture
Describe the TcPO2 measurements according to the type of fracture
Measured: Day 1
Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma
Describe the measures of TcPO2 according to comorbidities
Measured: Day 1
Patient scar assessment scale (PSAS grid) at S6 and S12
Describe the type of skin pain according to TcPO2 measurement The PSAS observation scale consists of 7 questions for the patient concerning pain, itching, colour, suppleness, thickness, appearance and a general opinion on the scar.
Each parameter is rated on a scale from 1 (best score) to 10 (worst score). The sum of the 7 parameters gives the total score (minimum value = 7 ; maximum value = 70).
Measured: Week 6
Patient scar assessment scale (PSAS grid) at S6 and S12
Describe the type of skin pain according to TcPO2 measurement The PSAS observation scale consists of 7 questions for the patient concerning pain, itching, colour, suppleness, thickness, appearance and a general opinion on the scar.
Each parameter is rated on a scale from 1 (best score) to 10 (worst score). The sum of the 7 parameters gives the total score (minimum value = 7 ; maximum value = 70).
Measured: Week 12
OSAS Scale (observer scars assessment scale) at S6 and S12
Measure the quality of healing The OSAS observation scale consists of seven parameters (vascularization, pigmentation, thickness, relief, plasticity, surface and a global evaluation).
Each parameter is rated on a scale ranging from 1 ("like normal skin") to 10 ("the worst scar imaginable").
The sum of the 7 parameters gives the observer's total score (minimum value = 7 ; maximum value = 70).
Measured: Week 6
OSAS Scale (observer scars assessment scale) at S6 and S12
Measure the quality of healing The OSAS observation scale consists of seven parameters (vascularization, pigmentation, thickness, relief, plasticity, surface and a global evaluation).
Each parameter is rated on a scale ranging from 1 ("like normal skin") to 10 ("the worst scar imaginable").
The sum of the 7 parameters gives the observer's total score (minimum value = 7 ; maximum value = 70).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start3 Feb 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Brulefert, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209582
- Sponsor's protocol ID
- RC19_0303
- Acronym
- TAC
- Status last verified
- Sep 2021
- First submitted
- 20 Dec 2019
- Last updated
- 27 Sep 2021
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
- ClinicalTrials.gov ID
- NCT04209582
- Acronym / sponsor ID
- TAC / RC19_0303
- Conditions
- Ankle Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 24 Dec 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.
This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.
Detailed description
This prospective observational study aims to determine the limit of TcPO2 predictive of postoperative cutaneous pain in patients with ankle trauma.
A TcPO2 measurement will be performed preoperatively at the patient's arrival in the emergency room, then every day after the operation for 3 days and finally at the follow-up visits at 3 and 6 weeks.
The cutaneous pain is evaluated by a PSAS self-questionnaire (completed by the patient) and an OSAS questionnaire (completed by the surgeon). These grids evaluate the tolerance and cicatricial quality in the medium and long term by the operator and the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population studied concerns all adult patients suffering from ankle trauma requiring surgical management, it is heterogeneous, concerns all ages, regardless of co-morbidities. Minor patients and patients unable to give their consent will not be included.
Key inclusion criteria (1 listed)
- Patients with surgery of ankle trauma
Key exclusion criteria (4 listed)
- Patient who does not agree to participate
- Patient unable to express agreement (ex: unconscious)
- Minor patient
- Major patient under tutorship or curatorship
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 |
|---|---|---|
| measurement of TcPO2 with skin electrodemeasurement of TcPO2 with skin electrode | Device | – |
Primary outcome
Presence of postoperative skin pain within 3 months postoperatively
Time frame: 0-3 Month
10 secondary outcomes
Preoperative TcPO2 on the injured ankle and contralateral ankle
Time frame: day 0
Preoperative and postoperative day 1 TcPO2 on the injured ankle
Time frame: Day 1
Rates of postoperative complications related to S12 surgery and TcPO2 measurements
Time frame: 3 months
Surgical revision rate at S12 and TcPO2 measurements
Time frame: 3 months
Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture
Time frame: Day 1
Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma
Time frame: Day 1
Patient scar assessment scale (PSAS grid) at S6 and S12
Time frame: Week 6
Patient scar assessment scale (PSAS grid) at S6 and S12
Time frame: Week 12
OSAS Scale (observer scars assessment scale) at S6 and S12
Time frame: Week 6
OSAS Scale (observer scars assessment scale) at S6 and S12
Time frame: Week 12
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 27 Sep 2021.
- 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.
Kevin Brulefert, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries, run by Nantes University Hospital 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 1 inclusion and 4 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 27 Sep 2021. 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?
Presence of postoperative skin pain within 3 months postoperatively (time frame: 0-3 Month). 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 27 Sep 2021.