Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study. (TOP-ANK)

Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Drug: Oxygen; Other: no oxygen therapy

Detailed Description

Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • France
    • Nantes, France, France, 44000
      • Dr Gadbed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (A); Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization	Drug: Oxygen; administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.; Other Names: O2
Other: Control group (B); No oxygen therapy during hospitalization	Other: no oxygen therapy; No oxygen therapy during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous and infectious complications	Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observer Scar Assessment Scale (OSAS questionnaire)	The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points	3 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)	The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points	6 weeks after surgery
Observer Scar Assessment Scale (OSAS questionnaire)	The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points	12 weeks after surgery
Revision surgery		6 months after surgery
Pseudoarthrosis Complication	Presence of delayed healing on radiograph at S24	24 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	preoperatively
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	24 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	48 hours after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	3 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	6 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	12 weeks after surgery
Visual Analogue Scale (VAS) to evaluate ankle pain	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)	24 weeks after surgery
Transcutaneous oxygen pressure measurements (TcPO2)	The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)	before the initiation of oxygen therapy preoperatively
Transcutaneous oxygen pressure measurements (TcPO2)	The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)	48hours after surgery
Transcutaneous oxygen pressure measurements (TcPO2)	The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)	3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	pre-operatively
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	48 hours after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	3 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	6 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	12 weeks after surgery
EuroQol 5-Dimension (EQ-5D) self-questionnaire	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)	24 weeks after surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Radiometer Medical ApS

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures; Inorganic Chemicals; Elements; Chalcogens; Gases; Oxygen
• Other Study ID Numbers: RC21_0129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No