Supplementary Oxygen Therapy After Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a Pilot, Non-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of subjects included
研究概览
简要总结
A fracture-related infection (FRI) is a difficult to treat condition in which a bone fracture and surrounding tissues are infected. This results in impaired healing and ongoing symptoms such as pain, wound leakage and swelling, which affects patients' functioning and quality of life. Despite adequate treatment in the form of extensive surgical debridement and long-term antibiotics, it is hard to obtain infection eradication.
This pilot, non-blinded, randomized controlled trial (RCT) will assess the feasibility of a subsequent, larger RCT, in which hyperbaric oxygen therapy (HBOT) will be investigated as potential treatment modality for FRI in adjunction to standard care. HBOT induces an increased oxygen tension in the body and thereby inhibits inflammation and the growth of several bacteria. Furthermore, it stimulates bone and blood vessel formation. Therefore, HBOT might be of added value in the treatment of FRI. Data on process-related outcomes, patient-reported outcome measures, and clinical parameters are obtained during this pilot study to determine whether a subsequent study investigating the efficacy of HBOT is viable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
研究组 & 干预措施
Standard care
Subjects receive standard care, consisting of at least surgical debridement of the FRI and administration of antibiotics.
Hyperbaric oxygen therapy (HBOT) + standard care
Subjects receive 20 HBOT sessions within 30 days in addition to standard care. The first HBOT session will be conducted within 7 days after the index surgery in the context of FRI treatment.
干预措施: Hyperbaric Oxygen Therapy (Drug)
结局指标
主要结局
Number of subjects included
时间窗: 1 year
The total number of subjects included at the end of the inclusion period (i.e. one year after the start of the study)
Number of HBOT sessions completed by each subject in the intervention group
时间窗: Within 30 days after the first HBOT session
Amount of missing data per PROM per time point
时间窗: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
Number of complete questionnaires per PROM per timepoint
时间窗: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
次要结局
未报告次要终点
研究者
Professor Markus W Hollmann
MD PhD PhD Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)