NCT04209582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

December 20, 2019

Last Update Submit

September 24, 2021

Conditions

Ankle Injuries

Outcome Measures

Primary Outcomes (1)

  • Presence of postoperative skin pain within 3 months postoperatively

    0-3 Month

Secondary Outcomes (10)

  • Preoperative TcPO2 on the injured ankle and contralateral ankle

    day 0

  • Preoperative and postoperative day 1 TcPO2 on the injured ankle

    Day 1

  • Rates of postoperative complications related to S12 surgery and TcPO2 measurements

    3 months

  • Surgical revision rate at S12 and TcPO2 measurements

    3 months

  • Preoperative and postoperative day 1 TcPO2 on the injured ankle and type of fracture

    Day 1

  • +5 more secondary outcomes

Interventions

measurement of TcPO2 with skin electrodeDEVICE

measurement of TcPO2 with skin electrode

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with surgery of ankle trauma

You may not qualify if:

  • Patient who does not agree to participate
  • Patient unable to express agreement (ex: unconscious)
  • Minor patient
  • Major patient under tutorship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Kevin Brulefert, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

February 3, 2020

Primary Completion

July 9, 2021

Study Completion

July 9, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

FR(1)