Prevention of Retained Items iN Childbirth Environment and Surgical Sites (PRINCESS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retained Surgical Items
• Intervention / Treatment: Procedure: iCount Device

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)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Aditi Desai; Phone Number: 01902695166; Email: aditidesai@nhs.net
• Study Contact Backup: Name: Lorraine Jacques; Phone Number: 01902 695065; Email: lorraine.jacques@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iCount Device; A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner.	Procedure: iCount 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.
User Feedback Survey; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	12 months

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Collaborators: Innovate UK
• Investigators: Principal Investigator: Aditi Desai, The Royal Wolverhampton NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: 2024SUR130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No