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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of postoperative skin pain within 3 months postoperatively	0-3 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative TcPO2 on the injured ankle and contralateral ankle	compare TcPO2 values between healthy ankle and traumatized ankle	day 0
Preoperative and postoperative day 1 TcPO2 on the injured ankle	Compare TcPO2 values before and after surgery	Day 1
Rates of postoperative complications related to S12 surgery and TcPO2 measurements	Measure surgical complications based on TcPo2 measurements	3 months
Surgical revision rate at S12 and TcPO2 measurements	Measure the number of surgical revisions based on TcPo2 measurements	3 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Kevin Brulefert, MD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): July 9, 2021

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: RC19_0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No