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NCT Number: NCT06570304

Prevention of Retained Items iN Childbirth Environment and Surgical Sites

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under 18 years of age
  • Emergency surgery

Treatment and study plan

iCount Device

Procedure

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.

Primary outcomes

  1. Understanding user experience/usability factors

    Time frame: 12 months

    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.

  2. How the device sits within the current system

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aditi Desai

CONTACT

[email protected]

01902695166

Lorraine Jacques

CONTACT

[email protected]

01902 695065

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Collaborators

  • Innovate UK

Registry information

Official study title

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

Acronym: PRINCESS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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