An observational study in Retained Surgical Items, sponsored by The Royal Wolverhampton Hospitals NHS Trust. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by The Royal Wolverhampton Hospitals NHS Trust · Observational
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.
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality. (Birolini et al, 2016) 1
Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.
The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention. (Gawande et al, 2003)2 As the name suggests, a 'never event' should never happen. Unfortunately, incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.
Never-events involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?
Patient safety is a well-known priority for the European commission, WHO and the NHS. Some of the National/International reports highlighting this problem:
29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 19 observational studies indexed under Foreign Bodies.
Browse Foreign Bodies studies →The Royal Wolverhampton Hospitals NHS Trust is the lead sponsor of 51 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner.
Procedure: iCount Device
Anonymised feedback data will be collected from 20 staff users about the user experience and usability of the device. This will be conducted with an online survey questionnaire designed with advice from ergonomics experts after an extensive literature review of human factors-ergonomics principles and MHRA guidance about conducting medical device usability 5 staff users will be randomly selected from the consent forms to have semi-structured interviews developed in accordance with qualitative research methodology for medical device usability testing and user experience.
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.
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
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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The Royal Wolverhampton Hospitals NHS Trust