Prevention of Retained Items iN Childbirth Environment and Surgical Sites

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Royal Wolverhampton Hospitals NHS Trust

About this trial

To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients due to undergo surgery at the chosen NHS Trust.

Patients 18 years or older and consented to participation after an informed choice.

Disqualifiers

Under 18 years of age

Emergency surgery

Trial population

The participants will be pregnant women during labour. Staff who work in the operating theatres and are involved in performing swab and instrument counts. Consented to participation after an informed choice.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • iCount Device

    Procedure/Surgery

    Designed as single use. Intended purpose - To be used to count swabs and tampons after surgery in an objective manner. This is intended to be used in patients during and just after surgery. This is a device accessory.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: iCount Device1 intervention
Group B: User Feedback Survey0 interventions

Trial outcomes

Primary outcomes

1

Understanding user experience/usability factors

User responses on Likert scale for the various usability factors such as user confidence in the accuracy of counts, functional aspects and ease of use collected with an online software-assisted survey.

Time frame
12 months
2

How the device sits within the current system

The purpose is to obtain user centred narratives and a rich qualitative data. Semi-structured interviews of staff will be conducted via a virtual platform or in a safe face-to-face manner. These will be recorded with a dictaphone recording device or Microsoft teams auto-transcription

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: