TAC: Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain
Study Details
Study Description
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 | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Presence of postoperative skin pain within 3 months postoperatively [0-3 Month]
Secondary Outcome Measures
- Preoperative TcPO2 on the injured ankle and contralateral ankle [day 0]
compare TcPO2 values between healthy ankle and traumatized ankle
- Preoperative and postoperative day 1 TcPO2 on the injured ankle [Day 1]
Compare TcPO2 values before and after surgery
- Rates of postoperative complications related to S12 surgery and TcPO2 measurements [3 months]
Measure surgical complications based on TcPo2 measurements
- Surgical revision rate at S12 and TcPO2 measurements [3 months]
Measure the number of surgical revisions based on TcPo2 measurements
- Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture [Day 1]
Describe the TcPO2 measurements according to the type of fracture
- Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma [Day 1]
Describe the measures of TcPO2 according to comorbidities
- Patient scar assessment scale (PSAS grid) at S6 and S12 [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).
- Patient scar assessment scale (PSAS grid) at S6 and S12 [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).
- OSAS Scale (observer scars assessment scale) at S6 and S12 [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).
- OSAS Scale (observer scars assessment scale) at S6 and S12 [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with surgery of ankle trauma
Exclusion Criteria:
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Patient who does not agree to participate
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Patient unable to express agreement (ex: unconscious)
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Minor patient
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Major patient under tutorship or curatorship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantes University Hospital | Nantes | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Kevin Brulefert, MD, Nantes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC19_0303