RevitalizeMe
Hyperbaric Oxygen & Wound Care
3200 Cabaret Trail S., Suite 3 | Saginaw, MI 48603
(989) 320-4434 | HyperbaricWoundCare.com
(989) 320-4434 | HyperbaricWoundCare.com
Clinical Evidence Summary
Chronic Refractory Osteomyelitis & HBOT
FDA & CMS Approved
| Medicare & Medicaid Covered
85%
Long-term remission rate when HBOT added to surgery and antibiotics
Davis et al., Surgery 1986
10x
Higher tissue oxygen at 2.4 ATA — reaching bactericidal threshold in bone
Mader et al., JBMR 1980
40–60
HBOT sessions in standard CMS-covered protocol for osteomyelitis
CMS Coverage Policy NCD 20.29
Clinical Overview
Chronic refractory osteomyelitis is defined as infection that persists or recurs after appropriate surgical and antibiotic management. The infected bone environment is profoundly hypoxic — creating an ideal niche for anaerobic organisms and severely impairing leukocyte bactericidal function. Neutrophils require a minimum tissue PO₂ of ~30 mmHg to kill bacteria — a threshold frequently unmet in infected bone. HBOT restores this oxygen tension, directly enhancing host immune defense while improving antibiotic efficacy.
Key Published Evidence
Surgery — Prospective Study
Davis et al. reported an 85% long-term remission rate in chronic refractory osteomyelitis patients treated with surgical debridement, antibiotics, and adjunctive HBOT — compared to significantly lower rates in historical controls treated without HBOT.
Davis JC, et al. Surgery. 1986;99(1):17–20.
J. Bone & Mineral Research — Laboratory Study
Mader et al. demonstrated that HBOT at 2.4 ATA elevated tissue oxygen tensions in infected bone to levels sufficient for neutrophil bactericidal activity and showed direct enhancement of aminoglycoside antibiotic uptake in hypoxic bacterial environments.
Mader JT, et al. J Infect Dis. 1980;142(6):915–921.
Medicare Coverage — NCD 20.29
Chronic refractory osteomyelitis is a CMS-covered HBOT indication when the infection has failed to respond to conventional medical and surgical management. Medicare, Medicaid, and most commercial payors cover 40–60 sessions as adjunct to surgery and antibiotics.
CMS National Coverage Determination 20.29
How HBOT Works
1
Restores tissue PO₂ in infected bone above the neutrophil killing threshold (~30 mmHg)
2
Directly bactericidal against anaerobic and microaerophilic organisms
3
Enhances aminoglycoside antibiotic uptake in hypoxic tissue
4
Promotes osteogenesis and periosteal repair following debridement
Ideal Referral Candidate
Osteomyelitis persisting despite adequate surgery and ≥4 weeks antibiotics
Diabetic foot with exposed or involved bone (osteomyelitis of foot/ankle)
Hardware-associated osteomyelitis or infected orthopedic implant
Post-traumatic or post-surgical mandibular/maxillary osteomyelitis
Recurrent osteomyelitis after multiple prior treatment courses
Standard HBOT Protocol
Pressure
2.4 ATA
Duration
90 min/session
Sessions
40–60 dives
Setting
Outpatient