Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

Phase 2Not Yet RecruitingNCT07535164

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of subjects included

The total number of subjects included at the end of the inclusion period (i.e. one year after the start of the study)

Time frame: 1 year

Number of HBOT sessions completed by each subject in the intervention group

Time frame: Within 30 days after the first HBOT session

Amount of missing data per PROM per time point

Time frame: 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