Menu
Not yet recruiting NCT06570304

Prevention of Retained Items iN Childbirth Environment and Surgical Sites

Observational Retained Surgical Items

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iCount Device.
Who it may be relevant to
Registry conditions: Retained Surgical Items. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Understanding user experience/usability factors [Time frame: 12 months]
  • How the device sits within the current system [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06570304 · 2024SUR130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗