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Study on the Safety and Efficacy of Inhaled Hydrogen Therapy for Promoting Wound Healing in Patients after Lateral Skull Base Surgery

Study on the Safety and Efficacy of Inhaled Hydrogen Therapy for Promoting Wound Healing in Patients after Lateral Skull Base Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093246
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral skull base disease

Interventions

Experimental Group:Twice a day, 2 hours each time (9am-11am, 3pm-5pm), inhale a mixture of hydrogen and oxygen at a flow rate of 300mL/min for 4 hours through a three-way valve connected to a nasal ca
Control group:Twice a day, 2 hours each time (9 a.m.-11 a.m., 3 p.m.-5 p.m.), inhalation of a mixture of air and oxygen at a flow rate of 300 mL/min for 4 hours through a three-way valve connected to

Sponsors

Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients admitted to hospital with suspected lateral skull base lesions. The lateral skull base is an anatomical area bounded by the triangle between two imaginary lines, from the center of the nasopharyngeal roof wall, forward and outward through the pterygopalatine fossa to the front end of the inferior orbital fissure, and backward and outward through the jugular fossa to the posterior edge of the mastoid process. Lesions cover many common tumors in this area, including a) benign tumors, including paraganglioma, meningioma, and schwannoma; b) malignant tumors: temporal bone cancer. Since the diagnosis of lateral skull base lesions depends on histopathological diagnosis, the suspected diagnosis is determined by experienced lateral skull base surgeons based on the patient's clinical manifestations, physical examination, imaging examinations, intraoperative findings, and intraoperative rapid frozen pathology. 2 Patients who have undergone subtotal petrous bone resection or infratemporal fossa Type A/B/C/D surgery, and the operation went smoothly. The surgeon evaluated that the conditions for inclusion in the group were met: the patient was successfully weaned from the ICU and extubated, breathing independently, and could be safely returned to the general ward after surgery. 3 Patients can be transferred from the ICU (Intensive Care Unit) back to the general ward of the ENT department after clinical evaluation on the first day after surgery; 4 Adults aged 18 years or older;

Exclusion criteria

Exclusion criteria: 1 Patients with severe systemic diseases and poorly controlled conditions, such as autoimmune diseases, blood system diseases, diabetes, etc.; 2 Patients with infectious diseases such as hepatitis and syphilis; 3 Patients with concurrent infection in the surgical area during preoperative or intraoperative assessment, such as the presence of pus, positive pathogen culture, and infection foci found during surgery; 4 Patients who should undergo or have undergone tracheotomy after postoperative assessment; 5 Patients with cerebrospinal fluid leakage during surgery, which shall be assessed and confirmed by the surgeon in charge; 6 Patients with hypoxemia, manifested as oxygen saturation <90% without oxygen inhalation;

Design outcomes

Primary

MeasureTime frame
Time required for all wounds to achieve Grade A healing after surgery;

Secondary

MeasureTime frame
Laser Doppler speckle flowmeter detects blood flow value per unit area;Laser Doppler speckle flowmeter detects reflectance intensity per unit area;

Countries

China

Contacts

Public ContactGuodong Feng

Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences

fengguodong2013@163.com+86 150 0127 5266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026