TOP-ANK: Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| Other: Control group (B) No oxygen therapy during hospitalization |
Other: no oxygen therapy
No oxygen therapy during hospitalization
|
Outcome Measures
Primary Outcome Measures
- 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
- Observer Scar Assessment Scale (OSAS questionnaire) [3 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
- Observer Scar Assessment Scale (OSAS questionnaire) [6 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
- 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
- Revision surgery [6 months after surgery]
- Pseudoarthrosis Complication [24 weeks after surgery]
Presence of delayed healing on radiograph at S24
- Visual Analogue Scale (VAS) to evaluate ankle pain [preoperatively]
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 [24 hours after surgery]
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 [48 hours after surgery]
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 [3 weeks after surgery]
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 [6 weeks after surgery]
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 [12 weeks after surgery]
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 [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)
- Transcutaneous oxygen pressure measurements (TcPO2) [before the initiation of oxygen therapy preoperatively]
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
- Transcutaneous oxygen pressure measurements (TcPO2) [48hours after surgery]
The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)
- 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)
- EuroQol 5-Dimension (EQ-5D) self-questionnaire [pre-operatively]
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 [48 hours after surgery]
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 [3 weeks after surgery]
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 [6 weeks after surgery]
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 [12 weeks after surgery]
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 [24 weeks after surgery]
This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient over 18 years of age
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Patient with an ankle joint injury with surgical indication
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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
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Polytrauma patients
-
Pregnant or breastfeeding women or those refusing effective contraception
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Patient deprived of liberty or under legal protection (guardianship or curatorship)
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Patient unable to follow the protocol, as judged by the investigator
-
Patient refusing to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Gadbed | Nantes | France | 44000 |
Sponsors and Collaborators
- Nantes University Hospital
- Radiometer Medical ApS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC21_0129