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Can a simple oxygen tube cut surgery infections?

NCT ID NCT05185115

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether giving extra oxygen through a nasal tube during hospital stay can lower the chance of wound infections and skin issues after ankle surgery. It involves 200 adults who are at higher risk due to conditions like diabetes or smoking. Half receive oxygen, half do not, and their recovery is tracked for six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxygen
What this could lead to
If it works, this could provide a simple, low-cost way to reduce wound infections and skin problems after ankle surgery in people with risk factors like diabetes or smoking.
What could go wrong
This is a pilot study, so it's small and designed mainly to see if a larger trial is feasible. The results may not be conclusive, and oxygen therapy might not reduce complications significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Ankle Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle fractures

Contacts and locations

Locations

  • Dr Gadbed

    Nantes, France, 44000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.