Surgical Site InfectionNCT05090462
PICO Dressings for Emergency Laparotomy
An observational study of Surgical Site Infection, run by North Middlesex University Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- PICO dressing
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients (>/= 18 years) undergoing emergency (laparotomy) surgery at a single centre (North Middlesex University Hospital, London, UK) will be included.
Who may be able to join
- All emergency midline laparotomy
- Laparoscopic converted open
Who cannot join
- Reoperation with 28 days of index laparotomy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nader University Bedwani
London, N18 1QX
Nader U Bedwani, MRCS, nader.bedwani@nhs.net
About this study
Official title: The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy
SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient.
NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral.
The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.
- Conditions
- Surgical Site Infection
- Being tested
- PICO dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO dressingDevice
Negative Pressure Wound Therapy device
| Study group | Role | What they receive |
|---|---|---|
| Standard surgical dressings (Clearpore) | Not described | |
| NPWT dressing (PICO) | Not described Receives: Device: PICO dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI Day 7
Presence of SSI
Measured: Day 7
Secondary outcomes (6)
SSI Day 7
Presence of SSI
Measured: Day 28
Length of stay
Length of stay
Measured: through study completion, an average of 6 months
Surgical site complications
Number of participants with other complications of the wound to include dehiscence and burst abdomen
Measured: Day 28
Reoperation
Number of participants undergoing reoperation
Measured: Day 28
SSI grading
SSI grading as per Southampton scoring system (if applicable) (Grade 0-5 with 5 being worse outcome)
Measured: Day 28
Length of antibiotic therapy
Duration of post-operative antibiotic therapy
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Middlesex University Hospital NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nader Bedwani, North Middlesex University Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090462
- Sponsor's protocol ID
- 1234
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared through IRAS
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PICO Dressings for Patients Undergoing Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05090462
- Acronym / sponsor ID
- 1234
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- North Middlesex University Hospital NHS TrustOther government
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Oct 2021 (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.
SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient.
NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral.
The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard surgical dressings (Clearpore) | – | – |
| NPWT dressing (PICO) | – | Device: PICO dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (>/= 18 years) undergoing emergency (laparotomy) surgery at a single centre (North Middlesex University Hospital, London, UK) will be included.
Key inclusion criteria (2 listed)
- All emergency midline laparotomy
- Laparoscopic converted open
Key exclusion criteria (1 listed)
- Reoperation with 28 days of index laparotomy
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 |
|---|---|---|
| PICO dressingNegative Pressure Wound Therapy device | Device | NPWT dressing (PICO) |
Primary outcome
SSI Day 7
Time frame: Day 7
Presence of SSI
6 secondary outcomes
SSI Day 7
Time frame: Day 28
Length of stay
Time frame: through study completion, an average of 6 months
Surgical site complications
Time frame: Day 28
Reoperation
Time frame: Day 28
SSI grading
Time frame: Day 28
Length of antibiotic therapy
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Yes. Will be shared through IRAS
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by North Middlesex University Hospital NHS Trust at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI Day 7 (time frame: Day 7). 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 22 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.