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Journal of Orthopedic Education

Volume  5, Issue 1, January-April 2019, Pages 10-17
 

Original Article

Crush Injury: HBOT and Placebo Controlled Randomized Clinical Trail

Manoj Gupta

Director, Prana Hyperbaric Oxygen Therapy Center, Sailee Hospital & Diagnostic Center, Prathamesh Horizon New MHB Colony, New Link Road, Borivali West, Maharashtra 400091, India.

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DOI: DOI: http://dx.doi.org/10.21088/joe.2454.7956.5119.2

Abstract

Background: Hyperbaric Oxygen Therapy (HBO) is an established treatment modality, which is internationally practiced since a long time ago. International protocols for the practice of hyperbaric oxygen therapy have been established in the United States by the Undersea and Hyperbaric Medical Society (UHMS) and in Europe by the European Committee for Hyperbaric Medicine (ECHM). Objective: To look for outcome on Wound healing without tissue necrosis requiring surgical excision, new major surgical procedures in relation to progressive and massive revitalization after entry in trail, Time of healing and Length of hospitalization. Study Design: A prospective Randomized double blind placebo controlled trial performed to realize the aim and objectives of this study. Place of Study: The study was carried out at the Prana HBO Centre, which is owned by the Investigator and located in the Northern parts of Mumbai, in India. Methods: On receiving the patient to the HBO unit at Prana, patients were randomly assigned to receive HBO therapy or Placebo. HBO therapy was given with compressed with air at a pressure of 2.5 atmosphere absolute (ATA). At this pressure the patient breathed 100% oxygen via facial mask. The HBO therapy protocol included 90 minutes oxygen breathing at 2.5 ATA twice daily over 6 days as per study by G Bouachour et al. Placebo consisted of sessions in HBO chamber at a pressure of 1.1 ATA in order to stimulate compression and its effects on the ears, while the patient breathing normal air via facial mask. The placebo therapy included 90 minutes air breathing at 1.1 ata twice daily over 6 days. Results and Discussion: Total 60 patients completed the study period and no patient was excluded during the study analysis. The demographic profile was comparable in the two groups of HBO and Placebo group. It was observed in the study that complete wound healing without any tissue necrosis requiring any amount of surgical excision was observed in 24 patients in HBO group whereas only 13 patients were observed with complete healing in the Placebo group. There s a threefold effect of Hyper oxygenation in HBO Therapy, a typical treatment pressure of 2 ATA, the plasma and the tissue fluid oxygen tension increase 10 fold from about 100 and 30 mm hg respectively to more than 1000 mm hg in the plasma and more than 300 mm hg in the tissue fluids. Conclusion: HBO therapy is a very useful therapeutic adjunct especially in the management of severe trauma of the limbs in older patients with grade III soft tissue injuries. The side effects and complications of HBOT are so infrequent and/or minimal that contraindications for using this intervention as an adjunct in the management of crush injuries are almost nonexistent. However, in no situation should HBOT be used as a substitute for indicated surgical, orthopedic, and medical interventions.

Keywords: Crush Injuries; HBOT; Placebo; Clinical Trail.   


Corresponding Author : Manoj Gupta