Overview
Sponsor-declared trial summary
Oxygen therapy in trauma ankle surgery patients
To compare the complication rate of "at risk" patients who underwent trauma surgery of the ankle between 2 groups. Patients with at least one comorbidity and/or complex fracture were defined as "at risk": - Patient with a comorbidity defined at risk by the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes,…
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 21 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516578-31-00
- EudraCT number
- 2021-001497-28
- ClinicalTrials.gov
- NCT05185115
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the complication rate of "at risk" patients who underwent trauma surgery of the ankle between 2 groups. Patients with at least one comorbidity and/or complex fracture were defined as "at risk":
- Patient with a comorbidity defined at risk by the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)
- Patient with a complex fracture. Complex fractures are defined as dislocated bimalleolar fractures, trimalleolar fractures, distal quarter leg fractures, tibial pilon fractures, talus fractures and open fractures
Secondary objectives 6
- Compare the quality of healing between the two groups
- Compare the rate of revision surgery between the 2 groups
- Compare the delay in bone healing and the rate of pseudoarthrosis between the 2 groups
- To compare ankle pain between the 2 groups
- Compare the evolution of tissue oxygenation between the 2 groups in a subgroup of 40 patients
- Perform a cost-utility analysis (cost per QALY) comparing the 2 groups
Conditions and MedDRA coding
Oxygen therapy in trauma ankle surgery patients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10056697 | Tissue anoxia | 100000004867 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patient over 18 years of age
- Patient with at least one risk factor for scarring complications such as comorbidity(ies) and/or complex fracture
- Patient with at least one risk factor for scar complication, such as comorbidity(ies) and/or complex fracture: - Patient with a comorbidity defined as at risk in the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids, etc.). - Patients with complex fractures. Complex fractures include dislocated bimalleolar fractures, trimalleolar fractures, fractures of the distal quarter of the leg, tibial pilon fractures, talus fractures and open fractures.
Exclusion criteria 5
- Patient with chronic respiratory failure
- Patient with sleep apnea
- Patient with a bilateral ankle fracture
- Patient with polytrauma
- Patient on long-term oxygen therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.
Secondary endpoints 6
- Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12
- Surgical resumption within 6 months after surgery
- Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24
- Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24
- Measurement of TcPO2 before the start of oxygen therapy pre-operatively, then at H48, W3. These measurements will be performed in a subgroup of 40 patients (20 patients in each subgroup)
- Incremental cost-utility ratio over a 24-week time horizon (QALY assessed by EQ-5D self-questionnaire pre-operatively and at H48, W3, W6 and W12 and W24)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD404444 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, CRYOGENIC
- Route of administration
- INHALATION USE
- Max daily dose
- 3 l litre(s)
- Max total dose
- 15 l litre(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 34009 353 943 2 3
- MA holder
- LINDE FRANCE S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Coordonnateur
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Coordonnateur
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-08-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516578-31-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2024-516578-31-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Oxygen medicinal_SmPC_20221128 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-516578-31-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | France | Acceptable 2024-08-19
|
2024-08-21 |