2026-525871-24-00招募中2 期
Supplementary Oxygen Therapy after Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a pilot, non-blinded, randomized controlled trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of subjects included after one year study duration
研究概览
简要总结
The main objective of the SOLDIER pilot trial is to determine whether a subsequent randomized controlled trial on the potential added value of supplementary hyperbaric oxygen therapy in the treatment of fracture-related infection as performed using the current study design is feasible.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted
排除标准
- •Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 > 6.4 kPa
- •Patients with an early (i.e. diagnosed < 6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction
- •Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time)
- •Inability to understand Dutch or English
结局指标
主要结局
Number of subjects included after one year study duration
Number of subjects included after one year study duration
Number of HBOT sessions completed by each subject in the intervention group
Number of HBOT sessions completed by each subject in the intervention group
Completeness of acquired data on patient-reported outcome measures
Completeness of acquired data on patient-reported outcome measures
次要结局
未报告次要终点
研究者
Coordinating investigator
Scientific
Amsterdam UMC Stichting
研究点 (1)
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