Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-30 @ 9:50 AM
Study NCT ID:
NCT06570304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Retained Items iN Childbirth Environment and Surgical Sites
Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Organization:
Study Overview
Official Title:
Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRINCESS
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: