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NCT Number: NCT05185115

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Gadbed

Nantes, France, 44000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

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

Other names: O2

no oxygen therapy

Other

No oxygen therapy during hospitalization

Primary outcomes

  1. Cutaneous and infectious complications

    Time frame: 6 months

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

Secondary outcomes

  1. Observer Scar Assessment Scale (OSAS questionnaire)

    Time frame: 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

  2. Observer Scar Assessment Scale (OSAS questionnaire)

    Time frame: 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

  3. Observer Scar Assessment Scale (OSAS questionnaire)

    Time frame: 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

  4. Revision surgery

    Time frame: 6 months after surgery

  5. Pseudoarthrosis Complication

    Time frame: 24 weeks after surgery

    Presence of delayed healing on radiograph at S24

  6. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: preoperatively

    The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain)

  7. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  8. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  9. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  10. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  11. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  12. Visual Analogue Scale (VAS) to evaluate ankle pain

    Time frame: 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)

  13. Transcutaneous oxygen pressure measurements (TcPO2)

    Time frame: 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)

  14. Transcutaneous oxygen pressure measurements (TcPO2)

    Time frame: 48hours after surgery

    The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)

  15. Transcutaneous oxygen pressure measurements (TcPO2)

    Time frame: 3 weeks after surgery

    The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group)

  16. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: pre-operatively

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

  17. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: 48 hours after surgery

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

  18. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: 3 weeks after surgery

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

  19. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: 6 weeks after surgery

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

  20. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: 12 weeks after surgery

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

  21. EuroQol 5-Dimension (EQ-5D) self-questionnaire

    Time frame: 24 weeks after surgery

    This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Radiometer Medical ApS

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2022
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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