Xpand chest drain: Assessing equivalence to current standard therapy - A randomised controlled trial
Date
2006
Authors
Cooper C.
Hardcastle T.
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Abstract
Background. Penetrating chest trauma is a leading cause of admission to South African emergency departments. The resultant pneumo-/haemothoraces are currently routinely treated by means of standard underwater bottle drainage. A South African company, Sinapi Biomedical, recently launched the Xpand chest drain. This device incorporates a one-way valve with a fluid reservoir and permits the detection of an air leak, as well as intrapleural pressure differences. Aim. To prove equivalence of the Xpand chest drain compared with standard underwater bottle drainage. Methods. In a non-blinded randomised control trial 67 patients with radiological proof of a pneumo- or haemothorax following penetrating chest trauma were divided into two groups. One group received standard underwater drain treatment and the other group had the Xpand chest drain inserted. Time from placement of drain to removal of drain (following radiological proof of resolution) was compared between the two groups. Results. The underwater drain group (N = 34) had drainage periods varying from 6 to 280 hours with an average of 81.47 hours, while the Xpand group (N = 33) had drainage periods varying from 13 to 151 hours with an average of 61.04 hours (p = 0.088). Conclusions. Although there was a definite improvement in drainage time with the Xpand chest drain, the difference did not reach statistical significance. We have, however, proven that the Xpand chest drain is as effective as a standard underwater drain in treating the sequelae of penetrating chest trauma and therefore recommend it as an alternative to current standard therapy.
Description
Keywords
adult, article, cause of death, clinical trial, controlled clinical trial, controlled study, emphysema, equipment, hematothorax, human, lung hemodynamics, major clinical study, methodology, outcome assessment, penetrating trauma, pneumothorax, randomized controlled trial, statistical analysis, thorax drainage, thorax injury, thorax pressure, acute disease, instrumentation, South Africa, time, treatment outcome, tube, wound drainage, Acute Disease, Chest Tubes, Drainage, Humans, South Africa, Thoracic Injuries, Time Factors, Treatment Outcome, Wounds, Penetrating
Citation
South African Journal of Surgery
44
4
44
4