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

Phase 3

Recruiting

• Conditions: Ankle Fractures
• Interventions: Other: no oxygen therapy; Drug: Oxygen

• Registration Number: NCT05185115
• Lead Sponsor: Nantes University Hospital

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

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 Timeline

• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-11
• Study Start: 2022-04-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (B)	no oxygen therapy	No oxygen therapy during hospitalization
Intervention group (A)	Oxygen	Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Observer Scar Assessment Scale (OSAS questionnaire)	12 weeks after surgery	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
Pseudoarthrosis Complication	24 weeks after surgery	Presence of delayed healing on radiograph at S24
Revision surgery	6 months after surgery
Transcutaneous oxygen pressure measurements (TcPO2)	3 weeks after surgery	The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Visual Analogue Scale (VAS) to evaluate ankle pain	24 weeks after surgery	The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
EuroQol 5-Dimension (EQ-5D) self-questionnaire	24 weeks after surgery	This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

Trial Locations

Locations (1)

Dr Gadbed; 🇫🇷 Nantes, France