A regional multicentre review of the management and...

The Bluebelle Study: Feasibility study of complex, simple and absent wound

dressings in elective surgery

Phase B1: A multicentre study of wound dressings

SponsorsUniversity Hospitals Bristol NHS Foundation TrustR&D Office Level 3, Education CentreUpper Maudlin StreetBristol BS2 8AE

Key investigatorsTrainee Research Collaborative (Birmingham) Mr Andrew David Watt TorranceUniversity Hospitals Birmingham Email: [email protected]

Trainee Research Collaborative (Bristol)Miss Natalie BlencoweUniversity of Bristol

Email: [email protected]

Chief InvestigatorProfessor Jane BlazebyUniversity of Bristol

Principal Investigator at University Hospitals BirminghamMr Thomas PinkneyUniversity Hospitals Birmingham

Qualitative Research LeadProfessor Jenny DonovanUniversity of Bristol

Qualitative Research LeadDr Jonathan MathersUniversity of Birmingham

Methodological LeadProfessor Barney ReevesUniversity of Bristol

Statistical LeadDr Chris RogersUniversity of Bristol

Research Nurse LeadMs Katrina HurleySurgical Research TeamUniversity Hospitals Bristol NHS Trust

Wound nursing specialistMs Trudie YoungWelsh Wound Innovation Centre

Patient and Public Involvement LeaderDr Rachael Gooberman-HillUniversity of Bristol

Surgical Expertise and LeadershipMr Tim DraycottUniversity of Bristol

Bluebelle Wound dressing survey V1.0 P a g e | 1 2nd December 2014

mailto:University

Surgical Expertise and LeadershipMr Robert LongmanUniversity Hospitals Bristol NHS Trust

Surgical Expertise and LeadershipMr Mark WoodwardUniversity Hospitals Bristol NHS Trust

Health Economics Expertise and LeadershipProfessor Joanna CoastUniversity of Birmingham

Health Economics ExpertDr Lazaros AndronisUniversity of Birmingham

EpidemiologistProfessor Melanie CalvertUniversity of Birmingham

Study Coordination & Management (Birmingham)Dr Laura MagillClinical Trials Unit (University of Birmingham)

Academic F2 doctorDr Tom MilneUniversity of Bristol

Research AssociateMs Rhiannon MacefieldUniversity of Bristol

Qualitative ResearcherDr Leila RooshenasUniversity of Bristol

NIHR Doctoral FellowMr Barry MainUniversity of Bristol

Study contactsChief InvestigatorProfessor Jane BlazebyEmail: [email protected]

Study CoordinatorLucy EllisEmail:[email protected]


1. Introduction

Each year 4.5 million operations are performed in England and these are frequently complicated by

wound infections. Whilst many wound infections resolve with simple treatment, the more serious

ones cause pain, discomfort and may need prolonged hospital stays or further surgery. This has

major costs for the health services. Every effort is therefore made to minimise risks of developing

wound infections. One area of controversy is the role of wound dressings. Wound dressings range

from simple to complex with varying properties and some (complex) dressings may interact with the

wound to improve healing. Application of wound dressings is standard practice following surgery in

adults but it is rare to apply dressings to surgical wounds in children. Evidence about the effects of

wound dressings for the prevention of infection in surgical wounds, in adults and children, has been

scientifically reviewed. This found no evidence to suggest that covering surgical wounds with

dressings reduces the risk of wound infection, or that any particular wound dressing is more effective

than another. The evidence, however, is poor, and most studies are small and had design faults. The

review concluded that decisions on wound dressings should be based on dressing costs and

acceptability issues, such as how dressings may influence management of tissue fluid leaking from

the wound and it recommended more research. Another area of controversy is how wound infection

should be defined and measured. Current definitions vary and there is a lack of consensus. Better

ways of measuring wound infections are required that can be applied in everyday settings, and that

includes issues of importance to patients and health services.

2. Aims and scope

The overall aim of the Bluebelle feasibility study is to establish whether it is possible to carry out a

randomised trial to compare the effectiveness and cost-effectiveness of complex, or simple, and/or

no dressing to reduce wound infections following elective surgery and to develop a valid method for

assessment of wound infections to be used in the main trial. The study is divided into two main

parts. The first part, Phase A, is currently underway and comprises a qualitative research project.

This includes focused interviews undertaken with surgeons, nurses, midwives and patients in two

surgical specialties (gastrointestinal and obstetrics). Interviews are being conducted in two types of

hospital across two cities. This aims to investigate the current use of dressings and views about not

using dressings and compare these findings with interviews carried out with staff (surgeons and

nurses) in paediatric surgery (where dressings are not routinely used). Additional work to


standardise clinical assessment of wound infections is also underway. This involves interviews with

patients and staff to ask their views of the current questionnaires available to measure wound

infections and also to ask them what additional issues the questionnaires should include.

The second part of Phase A includes a multicentre survey of current practice in peri-operative wound

dressing use. This study aims to identify the types of dressing used to cover surgical wounds at the

end of an operation and the factors which may influence this choice. Combined with the qualitative

data outlined above, this information will be used to inform the planned interventional pilot study

(Phase B).

3. The Bluebelle Study – Multicentre wound dressing survey

3.1 Study design

This prospective study will collect data on the use of wound dressings in surgery. In the survey data

will be collected over a 2 week period (14 days) from 12/01/2014 until 23/01/2014. The aim is for

data from all surgical procedures (colorectal, upper GI and emergency cases) to be collected over

this time period. There will be minimum target of 30 cases at each centre (10 colorectal, 10 upper

GI, 10 emergency).

3.2 Eligibility

Elective and emergency operations performed by general (to include upper and lower

gastrointestinal surgery) at each centre will be eligible to be included in the study with permission of

the named consultant. Vascular, breast and gynaecological procedures will be excluded.

3.3 Identification of operations

Operations will be identified at each centre by the local investigating team in selected theatres.

3.4 Projected numbers

A total of 24 centres from the West Midlands (10 centres) and the South West (14 centres) will

undertake the prospective study. Each centre is expected to identify between 2 and 4 eligible

theatres and to collect data for at least 30 cases (10 colorectal, 10 upper GI, 10 emergency). Using

these figures it is estimated that data will be collected for around 720 procedures.


3.5 Study objectives

The objective of this study is to explore current practice in the use of peri-operative wound dressings

and to understand local hospital policy for purchasing wound dressings.

3.5.1 Primary objectives

The primary objective of this study is to identify the type of dressings used to cover surgical wounds

at the completion of elective operations. This includes the use of no dressing.

3.5.2 Secondary objectives:

Secondary objectives are outlined below. These include data that may influence choice of wound

dressings (Appendix A). In addition, a centre-specific questionnaire will address local policy in

dressing use and procurement (Appendix B).

3.6 Study outcomes

3.6.1 Primary outcome measure

The primary outcome measure of this study will be the type of dressing used to cover surgical

wounds at completion of operation. Specifically:

Was a dressing used?

Trade name of dressing and size (of each type of dressing used if multiple)

Number of dressings (of each type of dressing used if multiple)

ID number/barcode of each dressing type used

3.6.2 Secondary outcome measures

Specific details regarding secondary outcome measures are illustrated in the example pro-forma in

Appendix A.

1. Institutional details:

Name of hospital

2. Patient specific details

Age


Gender

BMI

3. Operative details

Date of operation

Grade of surgeon – (foundation doctor, core trainee, higher trainee or consultant)

Name of operation – to be completed at the end of the operation at time of sign out

procedure

Location of wound

Risk factors for wound infection (body mass index, ASA grade, diabetic status, stoma

formation)

3.6.3 Additional institutional data collection

A centre specific questionnaire (Appendix B) will be collected for each hospital participating in the

study. Data on local dressing procurement policy will include both global hospital procurement

policy at each site and more specific clinical and theatre-based dressing policies. Key policies and

decision makers will be identified and recorded.

3.7 Data collection

Anonymised data will be collected on paper data collection forms (Appendices A & B) and then

entered on to a specially designed password protected database stored on the web by the research

collaboratives and/or members from the Clinical Trials and Evaluation Unit in Bristol.

3.8 Study management

The study will be completed under the guidance of the Clinical Trials and Evaluation Unit working

closely with the Birmingham and the Bristol Surgical Trials Units. The study itself will be co-ordinated

by surgical trainees who are part of the West Midlands Research Collaborative (WMRC

http://www.wmresearch.org.uk/) and the Severn and Peninsula Audit and Research Collaborative for

Surgeons (SPARCS, http://www.sparcs.org.uk/) with support from the Bluebelle Study Coordinator.

The collaboratives have members who are trained in research and experience in participating in


http://www.sparcs.org.uk/

studies. Patients will be identified at 24 centres in across the two trainee collaborative networks. A

consultant surgeon at each site will oversee the study and be registered as the local lead. Local

research and development approval will be sought at each site. Data will be collected principally by

junior doctors. Local data will be returned to each hospital for audit purposes.

3.9 Data analysis

Data will be analysed in Stata and simple descriptive statistics will be used to summarise current

practice of the use of dressings.

3.10 Dissemination and authorship

It is anticipated that this survey will inform Phase B of the Bluebelle study. Additionally, the results

will be presented at national meetings and published in a peer reviewed journal. Centres who collect

data for at least 30 procedures will be asked to identify a maximum of 3 trainees in addition to the

to the centre lead and supervising consultant to be acknowledged as contributing authors in

publications arising from the study.

4. Study guide and timeframes for collaboratives and centres

Collaborative level

Collaborative leads to identify study lead within each collaborative

Study lead to publicise study and identify interested centres

Local study lead to be identified at each centre

Centre level

Local study lead to identify team at their centre

Consultant study lead to be approached and agree to act as supervisor/guarantor for the

study at a local level

Local hospital audit department approval must be sought and confirmation of this returned

to relevant collaborative study lead (See Appendix C)

Local study lead to identify eligible theatres for data collection


Local study lead to complete specific procurement questionnaire (Appendix B)

Local study lead to ensure data on all operations performed during study period is collected

and returned via the electronic data collection tool within 2 weeks of completion of the data

collection period


Appendix A – Data collection proforma


Appendix B – Centre specific dressing procurement questionnaire


Appendix C – Example audit registration form

©Natalie

All clinical audit projects should be registered before they start.

Please discuss your proposal with the appropriate Clinical Audit Facilitator. Contact details and guidance on completing this form are available via relevant workspace http://connect/governanceandquality/clinicalaudit/Pages/default.aspx

Title: see note 1

Surgical wound dressings: a multicentre evaluation of current practice

Your Details: Audit lead

Name Natalie Blencowe Division Surgery, Head and Neck

Position/Job Title Specialty registrar Specialty Surgery

Email [email protected] Tel Bleep

Project Team: see note 2

Name Job Title Specialty Role within Project (data collection, Supervisor etc)

Richard Bamford Specialty registrar Surgery Data collection

Sally Hallam Core trainee Surgery Data collection

Participation details: see note 2

What areas will this audit impact on? (e.g. Who in this area have you discussed and agreed this audit with?


ID No:

CLINICAL AUDIT PROJECT PLAN

http://connect/governanceandquality/clinicalaudit/Pages/default.aspx

another profession/specialty/Trust)Name Job Title Date Agreed

General surgery Jane Blazeby Professor of Surgery

Robert Longman Consultant colorectal surgeon

Background: see note 3

Each year 4.5 million operations are performed in England and these may frequently be complicated by wound infections. Whilst many wound infections resolve with simple treatment, the more serious ones cause pain, discomfort and may need prolonged hospital stays and further surgery. This has major costs for the health services. Every effort, therefore, is made to minimise risks of developing wound infections. One area of controversy is the role of wound dressings. Wound dressings range from simple to complex with varying properties and some (complex) dressings may interact with the wound to improve healing. Application of wound dressings is standard practice following surgery in adults but it is rare to apply dressings to surgical wounds in children. There is, however, no robust evidence to suggest that covering surgical wounds with dressings reduces the risk of wound infection, or that any particular wound dressing is more effective than another. Existing evidence is poor: most studies are small and have design faults.

Aim: see note 4

This clinical practice evaluation aims to identify which dressings are used to cover surgical wounds at the end of operations and the factors that may influence this choice. It also aims to establish local hospital policy for purchasing wound dressings.

Objectives: see note 4. You may find it is unnecessary to use the “Objectives” section i.e. “Aim” and “Criteria” may cover all the essential information.


STANDARDS

List standards as per example in first row. Be sure data you plan to collect will measure performance against listed standards.

Provide full information on source of standards – Title, website reference etc.

Criteria Target(%) Exceptions Source & Strength*

of EvidenceInstructions for where to find

data

E.G. At initial assessment urinary incontinence should be categorised as stress/mixed/urge 100%

NICE Guideline-CG 40

http://guidance.nice.org.uk/CG40

C Medical notes

1Assessment of whether dressings are used to cover wounds after general surgical procedures (and if so, which types)

100%

No good evidence from research studies, but the use of dressings is accepted as good clinical practice in general surgery

D Prospective data collection in the operating theatre

2 Understand how decisions are made about the types of wound dressings purchased in the hospital n/a nil

Survey procurement officers, tissue viability and theatre managers

3

*Strength of EvidenceA At least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendationB Availability of well-conducted clinical studies but no randomised clinical trials on the topic of the recommendationC Expert committee reports or opinions and/or clinical experience of respected authorities. Absence of directly applicable clinical studies of good qualityD Recommended good practice based on clinical experience (local consensus)

Bluebelle Wound dressing survey protocolV1.0 16 | P a g e 2nd December 2014

Data Collection Methodology (see note 5)

Casenote review

Prospective data collection

YData from existing

database(s)

Patient/

staff questionnaire

Y

Further details or other method

Please give details of how thishas been/will be piloted:

You must include your data collection form/spreadsheet with this proposed Audit Plan. Be sure the data items you’re collecting match the standards set

Audit Sample: see note 6

Sample selection criteria (i.e. patients

Identification of as many upper and lower gastrointestinal cases (elective and emergency) as possible during the audit period

Time period audited (i.e. Oct 12- Jan 13)

January 12th – 25th 2015

Estimated number of cases80

Who will provide list of patient (NB – need appropriate hospital / NHS numbers)

Not required

If you are requesting notes through the CA team, where would you like them delivered

Not required

Timescale/Deadlines: see note 6

Proposed start of data collection January 12th – 25th 2015

Proposed date for presentationof results

April 2015

Forum Divisional audit meeting

Proposed finish date i.e. after report and action plan produced

April 2015

Will you be leaving your current post in the near future?

No

If Yes, please give leaving date

If your project will not be finished by then, please identify and provide the name and job title of another member of staff who is willing to take over when you go

Are there any other deadlines you need to take into consideration?

No


Project Lead: I agree to ensure that this project is completed, the results disseminated, and a report given to my clinical audit facilitator. I understand that non-anonymised (staff/patient) audit data must not be taken outside the Trust. I understand that audit results belong to the Trust and that the project report may be made available to anyone who requests it.

Natalie Blencowe 25th October 2014

Project Lead Date

Senior Clinician / Manager: I confirm that this project has been agreed as part of the Specialty audit programme and that I will give my full support to it. I will ensure the dissemination of audit results and lead on the development and implementation of an action plan (if necessary) in order to obtain improvements in the quality of care provided.

Professor Jane Blazeby 25th October 2014

Senior Clinician/Manager Date

Clinical Audit Convenor: I approve the project described above and confirm that it has been appropriately reviewed for methodological quality, resource implication and importance to the Trust.

Clinical Audit Convenor Date


You need an appropriate senior clinician / manager to support the project. List below. Helpful to discuss with clinical audit team before seeking approval from senior colleague.

Once you have completed this form, please email it to the relevant Clinical Audit Facilitator, copying in your Senior Clinician / Manager

If this project is approved, the information on this form will be entered onto the Clinical Audit Project Management database.

You will be asked to complete a final report and action plan once the results of your audit are known. Detail of these will also be entered on the database.

A regional multicentre review of the management and...

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