OBJECTIVE: To compare the incidence of MEB during hyperbaric oxygen therapy using two different chamber compression protocols.
DESIGN: Double-blinded, randomized controlled trial.
SETTING: Hyperbaric Medicine Unit, The Townsville Hospital, Queensland, Australia, September 2012 to December 2014.
PATIENTS: 100 participants undergoing their first hyperbaric oxygen therapy session.
INTERVENTION: Random assignment to a staged (n=50) or a linear (n=50) compression protocols. Photographs of tympanic membranes were taken pre- and post-treatment and then graded. Middle ear barotrauma was defined as an increase of at least one grade on a modified TEED scale.
RESULTS: The observed MEB incidence under the staged protocol was 48% compared to 62% using the linear protocol (P=0.12, exact one-sided binomial test), and thus the staged protocol did not show a significant improvement in MEB. However, the staged protocol resulted in significantly less severe deteriorations in MEB grades when compared to the linear protocol (P=0.028, exact one-sided Mann-Whitney type test).
CONCLUSION: The use of the assessed staged compression protocol for the first hyperbaric oxygen treatment showed no significant effect on the overall incidence of MEB when compared to the gold standard linear protocol but resulted in a significant improvement in the severity of the experienced MEBs. Further studies are needed to elucidate an optimal compression protocol to minimize middle ear barotrauma.
METHODS: Fifty-eight diabetic patients with ulcers at Wagner Grade 2 and above involved in this study after presented at two study centres of tertiary teaching hospitals. The assigned patients received conventional wound care with additional HBOT given at 2.4 ATA for 90 minutes. Patients in the control group who received conventional wound care only were treated and observed for 30 days. The progress of wound healing was observed and measured at day 0, 10, 20 and 30 of study. The data collected were analysed using SPSS software (ver. 22) to study the association of HBOT towards healing of the diabetic foot ulcers.
RESULTS: Repeated Measures ANOVA analysis with Greenhouse-Geisser correction indicated that the means of wound size over time points (Day 0, 10, 20 and 30) among patients under HBOT group were statistically significantly different [F(1,61)=30.86, p<0.001)] compared to conventional therapy group. Multiple logistic regression analysis showed that HBOT group has nearly 44 times higher odds to achieve at least 30% wound size reduction within the study period (95%CI: 7.18, 268.97, p<0.001).
CONCLUSION: The results obtained in this study indicated that as an adjunctive therapy to conventional wound care, HBOT affected the rate of healing in diabetic foot ulcers significantly in terms of wound size reduction when compared to administering the conventional wound care alone.