Clinical trial NCT02937909: A Study to Evaluate the Benefits of Using a Range of Wound Care Products From a Single Manufacturer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound - in Medical Care
Keywords: woundcare community nursing competence
Lead sponsor: BSN Medical Ltd. UK
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 incurring less waste and reducing the number of referrals by the community nursing team to the Tissue Viability Team.

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.


Eligibility criteria: All healthcare professionals of the Billericay team responsible for dressing changes who are willing to take part in this study and give their written informed consent.

Inclusion Criteria for the patients:

* 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.

Exclusion Criteria for the patients:

* 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

Primary outcomes:
measure: Incidence of inappropriate use of dressings for the wound condition and patient lifestyle
timeFrame: At the end of 12 weeks treatment period
Secondary outcomes:
measure: Number of patients with wounds treated
timeFrame: At the end of 12 weeks treatment period
measure: Wound types treated
timeFrame: At the end of 12 weeks treatment period
measure: Total number of wound closure occurred
timeFrame: At the end of 12 weeks treatment period
measure: Average duration of treatment
timeFrame: At the end of 12 weeks treatment period
measure: Patients Quality of Life living with a Wound
timeFrame: At the start of the study and at the end of 12 weeks treatment period
measure: Confidence of healthcare professionals in their dressing selection
timeFrame: At the start of the study and at the end of 12 weeks treatment period
measure: Visual Analogue Scoring by the healthcare professionals of the simplification of training
timeFrame: At the end of 12 weeks treatment period
measure: Time required for training
timeFrame: At the end of 12 weeks treatment period
measure: NHS Trainer's time
timeFrame: At the end of 12 weeks treatment period
measure: NHS Trainer's cost
timeFrame: At the end of 12 weeks treatment period
measure: 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
timeFrame: At the end of 12 weeks treatment period
measure: Costs of dressings used
timeFrame: At the end of 12 weeks treatment period
measure: Number of wounds which could not be treated by the integrated range
timeFrame: At the end of 12 weeks treatment period
measure: Condition of wounds which could not be treated by the integrated range
timeFrame: At the end of 12 weeks treatment period
Other outcomes:
Locations:
city: Brentwood
country: United Kingdom
facility: South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital
state: Essex
Study officials:
affiliation: North East London NHS Foundation Trust
name: Ray Norris
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: British Broadcasting Corporation 10th Sept 2015 www.bbc.co.uk/news/ accessed 6th Oct 2015
citation: Cook L (2011) Assessment: exploring competency and current practice.British Journal of Community Nursing Wound care supplement 16. S34-40
citation: Dowsett C (2009) Use of TIME to improve community nurses' wound care knowledge and practice.. Wounds UK, Vol 5 No.3
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kerr (2014) How best to record and describe wound exudate Wounds UK Vol 10 No 2
citation: 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
citation: Office for National Statistics (2011) Topic Guide to Older People.
citation: Ousey K. Stephenson J et al (2013) Wound Care in five English NHS Trusts: Results of a Survey. Wounds UK Vol 9 No 4
citation: 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.
citation: Wicks G (2012) CQUIN Targets; effective dressing selection. Wound Essentials Vol 7 Issue 2 Nov
citation: 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.