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Table 10 Details of non-serious adverse events classified as ‘other’ and research nurses’ classification as to whether the event was considered to be related to the reference pressure ulcer

From: A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]

Events considered to be related to the reference pressure ulcer:

(n)

Deterioration of reference pressure ulcer

3

Increase in size/depth of reference pressure ulcer

2

Unable to remove Versafoam from wound*

1

Review of adverse event: removal of Versafoam*

1

Patient fell over VAC tubing and was unable to get off floor*

1

Increase in bleeding, wound malodorous and macerated to wound border

1

Events considered to be unrelated to the reference pressure ulcer:

( n )

Chest infection

2

Urinary tract infection

2

Generally unwell

2

Review of adverse event (Versafoam in ulcer)*

1

  1. *These non-serious adverse events were also considered to be definitely related to the trial treatment, as shown in Table 11.