Retained Surgical ItemsPRINCESSNCT06570304
Prevention of Retained Items iN Childbirth Environment and Surgical Sites
An observational study of Retained Surgical Items, run by The Royal Wolverhampton Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retained Surgical Items
- What is being tested?
- iCount Device
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients due to undergo surgery at the chosen NHS Trust.
- Patients 18 years or older and consented to participation after an informed choice.
Who cannot join
- Under 18 years of age
- Emergency surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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)
- Conditions
- Retained Surgical Items
- Being tested
- iCount Device
- Medical subject headings
- Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCount DeviceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| iCount Device | A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner. Receives: Procedure: iCount Device | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Surgical ItemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Innovate UK
- Responsible party
- Sponsor
- Investigators
- Aditi Desai, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570304
- Sponsor's protocol ID
- 2024SUR130
- Acronym
- PRINCESS
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study
- ClinicalTrials.gov ID
- NCT06570304
- Acronym / sponsor ID
- PRINCESS / 2024SUR130
- Conditions
- Retained Surgical Items
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- Innovate UK
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCount Device | – | Procedure: iCount DeviceA novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients due to undergo surgery at the chosen NHS Trust.
- Patients 18 years or older and consented to participation after an informed choice.
Key exclusion criteria (2 listed)
- Under 18 years of age
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCount DeviceDesigned 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. | Procedure or surgery | iCount Device |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Not yet recruitingObservational study
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aditi Desai principal investigator
The Royal Wolverhampton NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Surgical Items, run by The Royal Wolverhampton Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aditi Desai (01902695166, aditidesai@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding user experience/usability factors (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.