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

Primary Purpose

Ankle Fractures

Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Oxygen
no oxygen therapy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Gadbed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group (A)

Control group (B)

Arm Description

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

No oxygen therapy during hospitalization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Revision surgery
Pseudoarthrosis Complication
Presence of delayed healing on radiograph at S24
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)
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)
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)
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)
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)
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)
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)
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Transcutaneous oxygen pressure measurements (TcPO2)
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
December 23, 2021
Last Updated
January 10, 2022
Sponsor
Nantes University Hospital
Collaborators
Radiometer Medical ApS
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1. Study Identification

Unique Protocol Identification Number
NCT05185115
Brief Title
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
Acronym
TOP-ANK
Official Title
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Radiometer Medical ApS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (A)
Arm Type
Experimental
Arm Description
Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization
Arm Title
Control group (B)
Arm Type
Other
Arm Description
No oxygen therapy during hospitalization
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.
Intervention Type
Other
Intervention Name(s)
no oxygen therapy
Intervention Description
No oxygen therapy during hospitalization
Primary Outcome Measure Information:
Title
Cutaneous and infectious complications
Description
Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Observer Scar Assessment Scale (OSAS questionnaire)
Description
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
Time Frame
3 weeks after surgery
Title
Observer Scar Assessment Scale (OSAS questionnaire)
Description
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
Time Frame
6 weeks after surgery
Title
Observer Scar Assessment Scale (OSAS questionnaire)
Description
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
Time Frame
12 weeks after surgery
Title
Revision surgery
Time Frame
6 months after surgery
Title
Pseudoarthrosis Complication
Description
Presence of delayed healing on radiograph at S24
Time Frame
24 weeks after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
preoperatively
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
24 hours after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
48 hours after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
3 weeks after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
6 weeks after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
12 weeks after surgery
Title
Visual Analogue Scale (VAS) to evaluate ankle pain
Description
The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)
Time Frame
24 weeks after surgery
Title
Transcutaneous oxygen pressure measurements (TcPO2)
Description
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Time Frame
before the initiation of oxygen therapy preoperatively
Title
Transcutaneous oxygen pressure measurements (TcPO2)
Description
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Time Frame
48hours after surgery
Title
Transcutaneous oxygen pressure measurements (TcPO2)
Description
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
Time Frame
3 weeks after surgery
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
pre-operatively
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
48 hours after surgery
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
3 weeks after surgery
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
6 weeks after surgery
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
12 weeks after surgery
Title
EuroQol 5-Dimension (EQ-5D) self-questionnaire
Description
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Time Frame
24 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Gadbled, PH
Phone
02 40 08 37 78
Email
guillaume.gadbled@chu-nantes.fr
Facility Information:
Facility Name
Dr Gadbed
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Gadbed, PH
Phone
02 40 08 37 78
Email
guillaume.gadbled@chu-nantes.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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