Pilot randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people “STOPCUTS”: study protocol

Table 1 Tabulated study schedule

Study procedure	Set up (Visit 1)	Baseline/Study Day 0 (Visit 2)	Study Day 1 (the day after consent)	Upon new injury	Weekly* for 16 weeks	Study Day 112	Qualitative data collection
Identify potentially eligible participants	X
Provide Participant Information Sheet	X
Informed consent		X
Collection of baseline information		X
EQ5D-5 L questionnaire		X		X^c		X
ICECAP-O questionnaire		X		X^c		X
FES-I (short) questionnaire		X		X^c		X
Randomisation		X
Provision of socks (intervention arm only)		X
Wearing of socks (intervention arm only)			X --------------------------------- > X
Completion of participant diary (intervention arm only)			X --------------------------------- > X
Photograph wound				X^b
Measurement of wound				X^b
Wound scoring				X^b
Cardiff wound impact schedule^a				X^c		X^d
Adverse event recording			X --------------------------------- > X^e
Research nurse to visit care home for progress checks					X
Patient interviews							X
Focus groups							X

^*Regular contact (visit or telephone), approximately weekly.
^aCompleted only by participants who experienced one or more skin tear injuries during their study participation.
^bPerformed within one working day following injury.
^cPerformed seven days post-injury.
^dCompleted on Day 112 by all participants who experienced skin tear injury during the study. In addition, participants who incur an injury during week 16 (Day 106 to 112 inclusive), will also complete the questionnaire seven days post-injury.
^eDay 112 or Day 112 + 1 to 7 days if a skin tear injury occurs during week 16.

ISSN: 2055-5784