Wound InfectionProNounCENCT04110353

Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives

A study testing Wound dressings: Conservative dressings, Wound dressings: Prevena dressings and Wound dressings: ciVAC dressings in people with Wound Infection and Surgical Site Infection, run by Imperial College London.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study evaluates whether specialist negative pressure dressings reduce the risk of wound infections after operations when compared to conservative dressings, and if one negative pressure dressings works better than another. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Infection, Surgical Site Infection, Surgical Wound
What is being tested?: Wound dressings: Conservative dressings, Wound dressings: Prevena dressings and Wound dressings: ciVAC dressings
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2020to Jun 2022
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
Abdominal wounds closed at time of operation and expected to heal by primary intention
Patients who have the capacity to consent
To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
To including graft or flap sites as part of general surgical procedure
Patients who are able to complete questionnaires post operatively, either alone or with assistance

Who cannot join

Wounds where an appropriate seal cannot be obtained
Wounds left open and expected to heal by secondary intention
Patients known to have allergy or sensitivity to dressings being used
Patients who lack the capacity to consent

About this study

Official title: Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial

Read the detailed description

Surgical site infections (SSI) can affect up 41% of patients post-operatively. They are associated with significant healthcare and patient costs, and increased patient morbidity and mortality.

Specialist post operative dressings with negative pressure wound therapy are available, and the WHO do recommended for use in high risk wounds, taking resources into account. However no further recommendations are available.

This study will explore the rate of post-operative wound infections in adult patients undergoing open abdominal surgery on the bowel, and compare the rate of wound infections in these patients in relation to three different dressing types used after their operation. The study aims to determine if any of the dressings used within the study are associated with lower post-operative wound infection rates, and compare the overall costs of using each dressing type, including both direct healthcare costs and societal costs. Finally, it will evaluate participant's quality of life outcomes after open abdominal surgery, specifically relating to their wound.

Conditions: Wound Infection, Surgical Site Infection, Surgical Wound, Surgical Incision
Being tested: Wound dressings: Conservative dressings, Wound dressings: Prevena dressings, Wound dressings: ciVAC dressings
Keywords: Surgical Site infections, Negative Pressure Wound Therapy, Contaminated abdominal wounds, Closed incision abdominal wound, Prophylactic therapy
Medical subject headings: Wound Infection, Surgical Wound Infection, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wound dressings: Conservative dressingsOther
Conservative dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.
Wound dressings: Prevena dressingsOther
Prevena dressing to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.
Wound dressings: ciVAC dressingsOther
Closed incision VAC dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

Study groups in NCT04110353
Study group	Role	What they receive
Conservative dressings	Active comparator	Use of simple dressings on wound post operatively - to be placed at end of operation Receives: Other: Wound dressings: Conservative dressings
Prevena dressing	Active comparator	Use of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation Receives: Other: Wound dressings: Prevena dressings
ciVAC dressing	Active comparator	Use of closed incision VAC (vacuum assisted closure) dressing on wound post operatively - to be placed at end of operation Receives: Other: Wound dressings: ciVAC dressings

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical Site Infection
The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence
Measured: Up to day 90

Secondary outcomes (14)

Wound assessments - clinical assessment of presence of wound complication and healing
Independent blind assessment of wounds at day 7 post operatively, on discharge and at outpatient follow up, via wound photographs taken, and correlation with assessment by clinical team
Measured: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Length of stay
Length of stay post-operatively
Measured: Up to 90 days
Number of additional interventions received by participants due to development of a Surgical Site Infection
Need for intervention or treatment for surgical site infection (antibiotics, opening up of wound at bedside, operative or radiological intervention)
Measured: Within 30 days
Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections
Culture results if SSI post-operative (including sensitivities)
Measured: Within 30 days
Post operative complications - other
Occurrence of other post-operative complications
Measured: Within 30 days
Number of adverse reactions to treatments for Surgical Site Infections
Adverse reactions to antibiotics given or to dressings use
Measured: Within 30 days
Wound dressings - use of
Time to discontinuation of dressings, type and number of dressings used
Measured: Up to day 30-40
Ninety day mortality rate
Mortality within 90 days
Measured: Up to day 90
Ninety day readmission rate
Rate of readmission within 90 days
Measured: Up to day 90
Cause of death
Cause of death for any mortalities within 90 days
Measured: Up to day 90
Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire
Generic quality of life outcome measures using EQ5D5L questionnaire assessed at day 7 post operatively, on discharge and at outpatient follow up; individualised questions, no formal scale
Measured: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Quality of life measures: Wound Quality of Life questionnaires
Wound specific quality of life outcome measures using Wound Quality of Life questionnaire assessed at day 7 post operatively, on discharge and at outpatient follow up; scales - not at all/a little/moderately/quite a lot/very much
Measured: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Quality of life and economic measures: Economic assessment questionnaire
Assessment of economic impact of wound using single Economic questionnaire to be assessed at day 40; individualised questions that will be assessed, no formal scale
Measured: At day 40
Long term follow up - Hernia occurrence
Development of incisional hernia
Measured: At 1, 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2020Jun 2022

First posted1 Oct 2019
Study startJun 2020 (estimated)
Primary completionJun 2021 (estimated)
Study completionJun 2022 (estimated)

Why it stopped: Lack of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Wound InfectionStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Model description: Stepped wedge design with randomisation at the level of the Hospitals not individual patients
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04110353
Sponsor's protocol ID: 19IC5400
Acronym: ProNounCE
Status last verified: Sep 2023
First submitted: 20 Sep 2019
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Wound Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial
ClinicalTrials.gov ID: NCT04110353
Acronym / sponsor ID: ProNounCE / 19IC5400
Conditions: Wound Infection, Surgical Site Infection, Surgical Wound, Surgical Incision
Keywords: Surgical Site infections, Negative Pressure Wound Therapy, Contaminated abdominal wounds, Closed incision abdominal wound, Prophylactic therapy
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of funding
Enrolment: 0 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: Jun 2020 (estimated)
Primary completion: Jun 2021 (estimated)
Study completion: Jun 2022 (estimated)
First posted: 1 Oct 2019 (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.

Detailed description

Surgical site infections (SSI) can affect up 41% of patients post-operatively. They are associated with significant healthcare and patient costs, and increased patient morbidity and mortality.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Stepped wedge design with randomisation at the level of the Hospitals not individual patients

Arm	Type	Receives
Conservative dressings	Active comparator	Other: Wound dressings: Conservative dressingsUse of simple dressings on wound post operatively - to be placed at end of operation
Prevena dressing	Active comparator	Other: Wound dressings: Prevena dressingsUse of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation
ciVAC dressing	Active comparator	Other: Wound dressings: ciVAC dressingsUse of closed incision VAC (vacuum assisted closure) dressing on wound post operatively - to be placed at end of operation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
Abdominal wounds closed at time of operation and expected to heal by primary intention
Patients who have the capacity to consent
To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
To including graft or flap sites as part of general surgical procedure

Key exclusion criteria (4 listed)

Wounds where an appropriate seal cannot be obtained
Wounds left open and expected to heal by secondary intention
Patients known to have allergy or sensitivity to dressings being used
Patients who lack the capacity to consent

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
Wound dressings: Conservative dressingsConservative dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.	Other	Conservative dressings
Wound dressings: Prevena dressingsPrevena dressing to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.	Other	Prevena dressing
Wound dressings: ciVAC dressingsClosed incision VAC dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.	Other	ciVAC dressing

Primary outcome

Surgical Site Infection
Time frame: Up to day 90
The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence

14 secondary outcomes

Wound assessments - clinical assessment of presence of wound complication and healing
Time frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Length of stay
Time frame: Up to 90 days
Number of additional interventions received by participants due to development of a Surgical Site Infection
Time frame: Within 30 days
Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections
Time frame: Within 30 days
Post operative complications - other
Time frame: Within 30 days
Number of adverse reactions to treatments for Surgical Site Infections
Time frame: Within 30 days
Wound dressings - use of
Time frame: Up to day 30-40
Ninety day mortality rate
Time frame: Up to day 90
Ninety day readmission rate
Time frame: Up to day 90
Cause of death
Time frame: Up to day 90
Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire
Time frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Quality of life measures: Wound Quality of Life questionnaires
Time frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
Quality of life and economic measures: Economic assessment questionnaire
Time frame: At day 40
Long term follow up - Hernia occurrence
Time frame: At 1, 3 and 5 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Individual participant dataSharing planned: No

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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.

Christopher Peters principal investigator

Imperial College London

Carolynne Vaizey study chair

St Mark's Hospital and Academic Institute

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Sep 2023. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Site Infection (time frame: Up to day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110353.

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 28 Sep 2023.