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

Ankle Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185115
• Other study ID #: RC21_0129
• Status: Recruiting
• Phase: Phase 3
• Start date: April 9, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Nantes University Hospital
• Contact: Guillaume Gadbled, PH
• Phone: 02 40 08 37 78
• Email: guillaume.gadbled[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Postoperative Complications

Intervention

Drug:
• Oxygen
administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.

Other:
• no oxygen therapy
No oxygen therapy during hospitalization

Locations

Country	Name	City	State
France	Dr Gadbed	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Radiometer Medical ApS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous and infectious complications	Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Revision surgery		6 months after surgery
Secondary	Pseudoarthrosis Complication	Presence of delayed healing on radiograph at S24	24 weeks after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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