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Completed

NCT Number: NCT04209582

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

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.

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Key information

Conditions

Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measurement of TcPO2 with skin electrode

Device

measurement of TcPO2 with skin electrode

Primary outcomes

  1. Presence of postoperative skin pain within 3 months postoperatively

    Time frame: 0-3 Month

Secondary outcomes

  1. Preoperative TcPO2 on the injured ankle and contralateral ankle

    Time frame: day 0

    compare TcPO2 values between healthy ankle and traumatized ankle

  2. Preoperative and postoperative day 1 TcPO2 on the injured ankle

    Time frame: Day 1

    Compare TcPO2 values before and after surgery

  3. Rates of postoperative complications related to S12 surgery and TcPO2 measurements

    Time frame: 3 months

    Measure surgical complications based on TcPo2 measurements

  4. Surgical revision rate at S12 and TcPO2 measurements

    Time frame: 3 months

    Measure the number of surgical revisions based on TcPo2 measurements

  5. Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture

    Time frame: Day 1

    Describe the TcPO2 measurements according to the type of fracture

  6. 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

    Describe the measures of TcPO2 according to comorbidities

  7. Patient scar assessment scale (PSAS grid) at S6 and S12

    Time frame: Week 6

    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).

  8. Patient scar assessment scale (PSAS grid) at S6 and S12

    Time frame: Week 12

    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).

  9. OSAS Scale (observer scars assessment scale) at S6 and S12

    Time frame: Week 6

    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).

  10. OSAS Scale (observer scars assessment scale) at S6 and S12

    Time frame: Week 12

    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).

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: TAC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2019
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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