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

Ankle Injuries Clinical Trial

— TAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209582
• Other study ID #: RC19_0303
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of postoperative skin pain within 3 months postoperatively		0-3 Month
Secondary	Preoperative TcPO2 on the injured ankle and contralateral ankle	compare TcPO2 values between healthy ankle and traumatized ankle	day 0
Secondary	Preoperative and postoperative day 1 TcPO2 on the injured ankle	Compare TcPO2 values before and after surgery	Day 1
Secondary	Rates of postoperative complications related to S12 surgery and TcPO2 measurements	Measure surgical complications based on TcPo2 measurements	3 months
Secondary	Surgical revision rate at S12 and TcPO2 measurements	Measure the number of surgical revisions based on TcPo2 measurements	3 months
Secondary	Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture	Describe the TcPO2 measurements according to the type of fracture	Day 1
Secondary	Preoperative and postoperative day 1 TcPO2 on the injured ankle and comorbidities such as pulmonary pathologies, microangiopathy, vascular pathologies, history of trauma	Describe the measures of TcPO2 according to comorbidities	Day 1
Secondary	Patient scar assessment scale (PSAS grid) at S6 and S12	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).	Week 6
Secondary	Patient scar assessment scale (PSAS grid) at S6 and S12	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).	Week 12
Secondary	OSAS Scale (observer scars assessment scale) at S6 and S12	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).	Week 6
Secondary	OSAS Scale (observer scars assessment scale) at S6 and S12	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).	Week 12