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

Completed

• Conditions: Ankle Injuries

• Registration Number: NCT04209582
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Study Start: 2020-02-03
• Primary Completion: 2021-07-09
• Study Completion: 2021-07-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of postoperative skin pain within 3 months postoperatively	0-3 Month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France