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Prevention of Retained Items iN Childbirth Environment and Surgical Sites

Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06570304
Acronym
PRINCESS
Enrollment
30
Registered
2024-08-26
Start date
2026-06-30
Completion date
2027-06-30
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Surgical Items

Brief summary

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.

Detailed description

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: * CQC-Opening the door to change (2018) * US Joint Commission report: Preventing unintended retained foreign objects (2019) * The Australian Commission on Safety and Quality in Health Care and The New Zealand Health Quality and Safety Commission (2015) * Healthcare Safety Investigation Branch (HSIB,UK) investigation I2018/025 (2019)

Interventions

PROCEDUREiCount Device

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.

Sponsors

Innovate UK
CollaboratorOTHER_GOV
The Royal Wolverhampton Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Patients due to undergo surgery at the chosen NHS Trust. 2. Patients 18 years or older and consented to participation after an informed choice.

Exclusion criteria

1. Under 18 years of age 2. Emergency surgery

Design outcomes

Primary

MeasureTime frameDescription
Understanding user experience/usability factors12 monthsUser 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.
How the device sits within the current system12 monthsThe 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

Contacts

Primary ContactAditi Desai
aditidesai@nhs.net01902695166
Backup ContactLorraine Jacques
lorraine.jacques@nhs.net01902 695065

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026