Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570304
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Prevention of Retained Items iN Childbirth Environment and Surgical Sites
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 20032 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 NationalInternational 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 HSIBUK investigation I2018025 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 20032 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 NationalInternational 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 HSIBUK investigation I2018025 2019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None