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Clinical Trials/NCT04209582
NCT04209582
Completed
Not Applicable

Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain

Nantes University Hospital1 site in 1 country39 target enrollmentFebruary 3, 2020
ConditionsAnkle Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Injuries
Sponsor
Nantes University Hospital
Enrollment
39
Locations
1
Primary Endpoint
Presence of postoperative skin pain within 3 months postoperatively
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2020
End Date
July 9, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Presence of postoperative skin pain within 3 months postoperatively

Time Frame: 0-3 Month

Secondary Outcomes

  • Surgical revision rate at S12 and TcPO2 measurements(3 months)
  • Rates of postoperative complications related to S12 surgery and TcPO2 measurements(3 months)
  • Preoperative and postoperative day 1 TcPO2 on the injured ankle(Day 1)
  • Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture(Day 1)
  • Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma(Day 1)
  • Preoperative TcPO2 on the injured ankle and contralateral ankle(day 0)
  • Patient scar assessment scale (PSAS grid) at S6 and S12(Week 12)
  • OSAS Scale (observer scars assessment scale) at S6 and S12(Week 12)

Study Sites (1)

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