Clinical trial NCT06570304: Prevention of Retained Items iN Childbirth Environment and Surgical Sites
Official title: Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Retained Surgical Items
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Innovate UK
First posted: 2024-08-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Understanding user experience/usability factors
timeFrame: 12 months
measure: How the device sits within the current system
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: Aditi Desai
role: PRINCIPAL_INVESTIGATOR
References: