NCT05185115

Brief Summary

Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
5mo left

Started Apr 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress91%
Apr 2022Oct 2026

First Submitted

Initial submission to the registry

December 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 9, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

December 23, 2021

Last Update Submit

January 13, 2026

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

  • Cutaneous and infectious complications

    Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion

    6 months

Secondary Outcomes (21)

  • Observer Scar Assessment Scale (OSAS questionnaire)

    3 weeks after surgery

  • Observer Scar Assessment Scale (OSAS questionnaire)

    6 weeks after surgery

  • Observer Scar Assessment Scale (OSAS questionnaire)

    12 weeks after surgery

  • Revision surgery

    6 months after surgery

  • Pseudoarthrosis Complication

    24 weeks after surgery

  • +16 more secondary outcomes

Study Arms (2)

Intervention group (A)

EXPERIMENTAL

Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization

Drug: Oxygen

Control group (B)

OTHER

No oxygen therapy during hospitalization

Other: no oxygen therapy

Interventions

no oxygen therapyOTHER

No oxygen therapy during hospitalization

Control group (B)
OxygenDRUG

administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.

Also known as: O2
Intervention group (A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years of age
  • Patient with an ankle joint injury with surgical indication
  • Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture
  • Patient affiliated to a social security system
  • Patient having signed an informed consent

You may not qualify if:

  • Patient with chronic respiratory insufficiency
  • Patient with sleep apnea with equipment
  • Patient under long term oxygen therapy
  • Patient with a bilateral ankle fracture
  • Polytrauma patients
  • Pregnant or breastfeeding women or those refusing effective contraception
  • Patient deprived of liberty or under legal protection (guardianship or curatorship)
  • Patient unable to follow the protocol, as judged by the investigator
  • Patient refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Gadbed

Nantes, France, 44000, France

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

April 9, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)