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

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ClinicalTrials.gov Identifier: NCT04209582
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Ankle Injuries Device: measurement of TcPO2 with skin electrode

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: measurement of TcPO2 with skin electrode
    measurement of TcPO2 with skin electrode


Primary Outcome Measures :
  1. Presence of postoperative skin pain within 3 months postoperatively [ Time Frame: 0-3 Month ]

Secondary Outcome Measures :
  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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209582


Contacts
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Contact: Kevin Brulefert, MD 02 53 48 22 11 kevin.brulefert@chu-nantes.fr

Locations
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France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Kevin BRULEFERT, PH    02 53 48 22 11    kevin.brulefert@chu-nantes.fr   
Contact: Peggy AGENEAU    02.40.08.48.54    peggy.ageneau@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Kevin Brulefert, MD Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04209582    
Other Study ID Numbers: RC19_0303
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries