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Example 3.5 Protocol PRESSURE (2000) Part Section 9.1: Pressure‐relieving support surfaces: a randomised evaluation 9.1 Primary endpoint 9.1.1 Development of new pressure sores

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For each patient, the development of a Grade 2 or above pressure sore after randomisation and before discharge or trial completion due to improved mobility/activity, transfer to non‐participating centre, or 60 days from randomisation. This will include Grade 2 sores that develop from Grade 1a and 1b skin changes that were present at randomisation. For patients with existing Grade 2 sores, only sores developing at new sites will be considered as a new pressure sore. The surface area of new pressure sores will be recorded.

Randomised Clinical Trials

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