Wound - in Medical CareNCT02937909

A Study to Evaluate the Benefits of Using a Range of Wound Care Products From a Single Manufacturer

A study testing Use of wound care products from a single manufacturer in people with Wound - in Medical Care, run by BSN Medical Ltd. UK at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed to investigate whether the adoption of the use of a range of wound care products from a single manufacturer makes training in appropriate product selection more effective and results in more accurate selection of the appropriate product for the wound and for the patient's lifestyle, thereby… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound - in Medical Care
What is being tested?: Use of wound care products from a single manufacturer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Feb 2017to 6 Dec 2017
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

Patients giving their informed consent and with an open wound being treated by the community nursing team
All patients whose wounds can be treated with BSN medical UK Product range for wound and leg ulcer management.

Who cannot join

Age <18 years
Subjects who do not give their consent for any reason
Subjects who are unable to read and understand patient information sheet and consent form

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital
Brentwood, Essex, CM15 8DR

Other trials in United Kingdom

About this study

Official title: A Prospective Study With Historical Data Comparison to Evaluate the Benefits of Using a Range of Products From a Single Manufacturer for Training, Competencies in Wound Care and the Appropriate Use of Product

One community nursing team will switch to using a full range of dressings and compression products from BSN medical UK for three months. Nurse training on the products will be given and nurse competencies and confidence in woundcare and appropriate product selection will be tested at the start and end of the study.

The number and type of referrals to the Tissue Viability Team will be measured.

Total anonymised data on numbers of referrals, wound closure, numbers of wounds and quantity and cost of products used will be collected and compared with the historical record for three months prior to the study. Patients will complete a Quality of Life questionnaire at enrolment and exit from the study.

Patients for whom BSN medical UK products are not appropriate or not desired by the patient will not be enrolled and will receive the usual range of products available to the community nursing team.

Conditions: Wound - in Medical Care
Being tested: Use of wound care products from a single manufacturer
Keywords: woundcare community nursing competence

What participants receive

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

Use of wound care products from a single manufacturerOther
The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration

Study groups in NCT02937909
Study group	Role	What they receive
Prospective Data	Experimental	Use of BSN medical UK range of wound dressings and compression products for 12 weeks treatment period Training and testing of woundcare nursing competencies Quality of Life questionnaire for patients Receives: Other: Use of wound care products from a single manufacturer
Historical data	No intervention	Historical data from the three months prior to the study on time needed for nurse training, number of referrals to the Tissue Viability Team, costs of dressings used, number of patients with wounds treated, types of wounds, number of wound closures and duration of treatment .

What is being measured

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

Incidence of inappropriate use of dressings for the wound condition and patient lifestyle
As measured by referrals for case review to the Tissue Viability Team during the study
Measured: At the end of 12 weeks treatment period

Secondary outcomes (14)

Number of patients with wounds treated
Measured: At the end of 12 weeks treatment period
Wound types treated
Measured: At the end of 12 weeks treatment period
Total number of wound closure occurred
Measured: At the end of 12 weeks treatment period
Average duration of treatment
Measured: At the end of 12 weeks treatment period
Patients Quality of Life living with a Wound
as measured by use of the validated questionnaire Wound QoL.
Measured: At the start of the study and at the end of 12 weeks treatment period
Confidence of healthcare professionals in their dressing selection
as measured by written assessment
Measured: At the start of the study and at the end of 12 weeks treatment period
Visual Analogue Scoring by the healthcare professionals of the simplification of training
Measured: At the end of 12 weeks treatment period
Time required for training
Measured: At the end of 12 weeks treatment period
NHS Trainer's time
Measured: At the end of 12 weeks treatment period
NHS Trainer's cost
Measured: At the end of 12 weeks treatment period
Nurse's concordance with training measured by the total number of referrals to the tissue viability team caused by inappropriate dressing selections defined by the trust's guidelines
Measured: At the end of 12 weeks treatment period
Costs of dressings used
Measured: At the end of 12 weeks treatment period
Number of wounds which could not be treated by the integrated range
Measured: At the end of 12 weeks treatment period
Condition of wounds which could not be treated by the integrated range
Measured: At the end of 12 weeks treatment period

Timeline

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

15 Feb 20176 Dec 2017

First posted19 Oct 2016 (estimated)
Study start15 Feb 2017
Primary completion6 Dec 2017
Study completion6 Dec 2017

Why it stopped: Due to Inadequate patient recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Wound - in Medical CareStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02937909
Sponsor's protocol ID: WMC 75/UK/15
Status last verified: Mar 2018
First submitted: 31 Aug 2016
Last updated: 12 Mar 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
PubMed 24899053
British Broadcasting Corporation 10th Sept 2015 www.bbc.co.uk/news/ accessed 6th Oct 2015
Cook L (2011) Assessment: exploring competency and current practice.British Journal of Community Nursing Wound care supplement 16. S34-40
Dowsett C (2009) Use of TIME to improve community nurses' wound care knowledge and practice.. Wounds UK, Vol 5 No.3
Dowsett C, Bielby A, Searle R. Reconciling increasing wound care demands with available resources. J Wound Care. 2014 Nov;23(11):552, 554, 556-8 passim. doi: 10.12968/jowc.2014.23.11.552.
PubMed 25375403
Guest JF, Ayoub N, McIlwraith T, Uchegbu I, Gerrish A, Weidlich D, Vowden K, Vowden P. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open. 2015 Dec 7;5(12):e009283. doi: 10.1136/bmjopen-2015-009283.
PubMed 26644123
Huynh T, Forget-Falcicchio C. Assessing the primary nurse role in the wound healing process. J Wound Care. 2005 Oct;14(9):407-9. doi: 10.12968/jowc.2005.14.9.26832.
PubMed 16240619
Joy H, Bielby A, Searle R. A collaborative project to enhance efficiency through dressing change practice. J Wound Care. 2015 Jul;24(7):312, 314-7. doi: 10.12968/jowc.2015.24.7.312.
PubMed 26198553
Kerr (2014) How best to record and describe wound exudate Wounds UK Vol 10 No 2
McIntosh C, Ousey K (2008) A survey of nurses' and podiatrists' attitudes, skills and knowledge of lower extremity wound care. Wounds UK Vol 4 No 1
Office for National Statistics (2011) Topic Guide to Older People.
Ousey K. Stephenson J et al (2013) Wound Care in five English NHS Trusts: Results of a Survey. Wounds UK Vol 9 No 4
Smith G, Greenwood M, Searle R. Ward nurses' use of wound dressings before and after a bespoke education programme. J Wound Care. 2010 Sep;19(9):396-402. doi: 10.12968/jowc.2010.19.9.78229.
PubMed 20852568
Wicks G (2012) CQUIN Targets; effective dressing selection. Wound Essentials Vol 7 Issue 2 Nov
Wong I. Assessing the value of a leg ulcer education programme in Hong Kong. J Wound Care. 2003 Jan;12(1):17-9. doi: 10.12968/jowc.2003.12.1.26459.
PubMed 12572232

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?

See locations

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Clinical and Cost-Effectiveness of an Artificial Intelligence -Synthesized Nursing Care Bundle for Preventing Medical Device-Related Pressure Injuries
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Trauma Exposure, Trauma

All Wound - in Medical Care trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study With Historical Data Comparison to Evaluate the Benefits of Using a Range of Products From a Single Manufacturer for Training, Competencies in Wound Care and the Appropriate Use of Product
ClinicalTrials.gov ID: NCT02937909
Acronym / sponsor ID: WMC 75/UK/15
Conditions: Wound - in Medical Care
Keywords: woundcare community nursing competence
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to Inadequate patient recruitment
Enrolment: 21 participants (actual)
Lead sponsor: BSN Medical Ltd. UKIndustry (pharma, biotech, devices)
Study start: 15 Feb 2017 (actual)
Primary completion: 6 Dec 2017 (actual)
Study completion: 6 Dec 2017 (actual)
First posted: 19 Oct 2016 (estimated)
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.

The number and type of referrals to the Tissue Viability Team will be measured.

Patients for whom BSN medical UK products are not appropriate or not desired by the patient will not be enrolled and will receive the usual range of products available to the community nursing team.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prospective Data	Experimental	Other: Use of wound care products from a single manufacturerUse of BSN medical UK range of wound dressings and compression products for 12 weeks treatment period Training and testing of woundcare nursing competencies Quality of Life questionnaire for patients
Historical data	No intervention	–Historical data from the three months prior to the study on time needed for nurse training, number of referrals to the Tissue Viability Team, costs of dressings used, number of patients with wounds treated, types of wounds, number of wound closures and duration of treatment .

Who may qualify

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

Key inclusion criteria (2 listed)

Patients giving their informed consent and with an open wound being treated by the community nursing team
All patients whose wounds can be treated with BSN medical UK Product range for wound and leg ulcer management.

Key exclusion criteria (3 listed)

Age <18 years
Subjects who do not give their consent for any reason
Subjects who are unable to read and understand patient information sheet and consent form

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
Use of wound care products from a single manufacturerThe participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration	Other	Prospective Data

Primary outcome

Incidence of inappropriate use of dressings for the wound condition and patient lifestyle
Time frame: At the end of 12 weeks treatment period
As measured by referrals for case review to the Tissue Viability Team during the study

14 secondary outcomes

Number of patients with wounds treated
Time frame: At the end of 12 weeks treatment period
Wound types treated
Time frame: At the end of 12 weeks treatment period
Total number of wound closure occurred
Time frame: At the end of 12 weeks treatment period
Average duration of treatment
Time frame: At the end of 12 weeks treatment period
Patients Quality of Life living with a Wound
Time frame: At the start of the study and at the end of 12 weeks treatment period
Confidence of healthcare professionals in their dressing selection
Time frame: At the start of the study and at the end of 12 weeks treatment period
Visual Analogue Scoring by the healthcare professionals of the simplification of training
Time frame: At the end of 12 weeks treatment period
Time required for training
Time frame: At the end of 12 weeks treatment period
NHS Trainer's time
Time frame: At the end of 12 weeks treatment period
NHS Trainer's cost
Time frame: At the end of 12 weeks treatment period
Nurse's concordance with training measured by the total number of referrals to the tissue viability team caused by inappropriate dressing selections defined by the trust's guidelines
Time frame: At the end of 12 weeks treatment period
Costs of dressings used
Time frame: At the end of 12 weeks treatment period
Number of wounds which could not be treated by the integrated range
Time frame: At the end of 12 weeks treatment period
Condition of wounds which could not be treated by the integrated range
Time frame: At the end of 12 weeks treatment period

Results and safety

The study was stopped early (reason given: Due to Inadequate patient recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Background: PubMed 24899053Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
BackgroundBritish Broadcasting Corporation 10th Sept 2015 www.bbc.co.uk/news/ accessed 6th Oct 2015
BackgroundCook L (2011) Assessment: exploring competency and current practice.British Journal of Community Nursing Wound care supplement 16. S34-40
BackgroundDowsett C (2009) Use of TIME to improve community nurses' wound care knowledge and practice.. Wounds UK, Vol 5 No.3
Background: PubMed 25375403Dowsett C, Bielby A, Searle R. Reconciling increasing wound care demands with available resources. J Wound Care. 2014 Nov;23(11):552, 554, 556-8 passim. doi: 10.12968/jowc.2014.23.11.552.
Background: PubMed 26644123Guest JF, Ayoub N, McIlwraith T, Uchegbu I, Gerrish A, Weidlich D, Vowden K, Vowden P. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open. 2015 Dec 7;5(12):e009283. doi: 10.1136/bmjopen-2015-009283.
Background: PubMed 16240619Huynh T, Forget-Falcicchio C. Assessing the primary nurse role in the wound healing process. J Wound Care. 2005 Oct;14(9):407-9. doi: 10.12968/jowc.2005.14.9.26832.
Background: PubMed 26198553Joy H, Bielby A, Searle R. A collaborative project to enhance efficiency through dressing change practice. J Wound Care. 2015 Jul;24(7):312, 314-7. doi: 10.12968/jowc.2015.24.7.312.
BackgroundKerr (2014) How best to record and describe wound exudate Wounds UK Vol 10 No 2
BackgroundMcIntosh C, Ousey K (2008) A survey of nurses' and podiatrists' attitudes, skills and knowledge of lower extremity wound care. Wounds UK Vol 4 No 1
BackgroundOffice for National Statistics (2011) Topic Guide to Older People.
BackgroundOusey K. Stephenson J et al (2013) Wound Care in five English NHS Trusts: Results of a Survey. Wounds UK Vol 9 No 4
Individual participant dataSharing planned: No

Related trials for Wound - in Medical Care

Recruiting
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
RecruitingObservational study
Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions
Exanguination, Trauma Coagulopathy
Not yet recruiting
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Skin Injury, Premature Birth
Not yet recruiting
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Medical Device Related Pressure Ulcer (MDRPU), Pressure Injury
Recruiting
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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.

Ray Norris principal investigator

North East London NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Use of wound care products from a single manufacturer in people with Wound - in Medical Care, run by BSN Medical Ltd. UK 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 3 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: stopped early, as of the sponsor's last update on 12 Mar 2018. 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?

The study was stopped early (reason given: Due to Inadequate patient recruitment). Results are not available in the source record.

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?

Incidence of inappropriate use of dressings for the wound condition and patient lifestyle (time frame: At the end of 12 weeks treatment period). 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 NCT02937909, which also lists 15 linked publications.

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 12 Mar 2018.