Clinical trial NCT04209582: Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
Official title: Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with surgery of ankle trauma

Exclusion Criteria:

* Patient who does not agree to participate
* Patient unable to express agreement (ex: unconscious)
* Minor patient
* Major patient under tutorship or curatorship

Primary outcomes:
measure: Presence of postoperative skin pain within 3 months postoperatively
timeFrame: 0-3 Month
Secondary outcomes:
measure: Preoperative TcPO2 on the injured ankle and contralateral ankle
timeFrame: day 0
measure: Preoperative and postoperative day 1 TcPO2 on the injured ankle
timeFrame: Day 1
measure: Rates of postoperative complications related to S12 surgery and TcPO2 measurements
timeFrame: 3 months
measure: Surgical revision rate at S12 and TcPO2 measurements
timeFrame: 3 months
measure: Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture
timeFrame: Day 1
measure: Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma
timeFrame: Day 1
measure: Patient scar assessment scale (PSAS grid) at S6 and S12
timeFrame: Week 6
measure: Patient scar assessment scale (PSAS grid) at S6 and S12
timeFrame: Week 12
measure: OSAS Scale (observer scars assessment scale) at S6 and S12
timeFrame: Week 6
measure: OSAS Scale (observer scars assessment scale) at S6 and S12
timeFrame: Week 12
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Kevin Brulefert, MD
role: PRINCIPAL_INVESTIGATOR
References: