Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

Официальное название

Supplementary Oxygen Therapy After Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a Pilot, Non-blinded, Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Hyperbaric Oxygen Therapy
  Each HBOT session will be conducted in accordance with the following protocol: three 20 minute blocks and one 15 minute block of 100% oxygen breathing at 2.4 ATA, split up by 5 minutes of oxygen rest (i.e. breathing air with 21% oxygen at 2.4 ATA)

Первичные конечные точки

• Number of subjects included [Срок оценки: 1 year]
• Number of HBOT sessions completed by each subject in the intervention group [Срок оценки: Within 30 days after the first HBOT session]
• Amount of missing data per PROM per time point [Срок оценки: 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 [Срок оценки: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT07535164 · SOLDIER-2026 · 2026-525871-24-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗