Study Stopped
Due to Inadequate patient recruitment
A Study to Evaluate the Benefits of Using a Range of Wound Care Products From a Single Manufacturer
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
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2017
CompletedMarch 12, 2018
March 1, 2018
10 months
August 31, 2016
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At the end of 12 weeks treatment period
Secondary Outcomes (14)
Number of patients with wounds treated
At the end of 12 weeks treatment period
Wound types treated
At the end of 12 weeks treatment period
Total number of wound closure occurred
At the end of 12 weeks treatment period
Average duration of treatment
At the end of 12 weeks treatment period
Patients Quality of Life living with a Wound
At the start of the study and at the end of 12 weeks treatment period
- +9 more secondary outcomes
Study Arms (2)
Prospective Data
EXPERIMENTALUse 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 INTERVENTIONHistorical 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 .
Interventions
The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital
Brentwood, Essex, CM15 8DR, United Kingdom
Related Publications (15)
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.
PMID: 24899053BACKGROUNDBritish 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
BACKGROUNDDowsett 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.
PMID: 25375403BACKGROUNDGuest 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.
PMID: 26644123BACKGROUNDHuynh 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.
PMID: 16240619BACKGROUNDJoy 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.
PMID: 26198553BACKGROUNDKerr (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
BACKGROUNDSmith 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.
PMID: 20852568BACKGROUNDWicks G (2012) CQUIN Targets; effective dressing selection. Wound Essentials Vol 7 Issue 2 Nov
BACKGROUNDWong 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.
PMID: 12572232BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Ray Norris
North East London NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
October 19, 2016
Study Start
February 15, 2017
Primary Completion
December 6, 2017
Study Completion
December 6, 2017
Last Updated
March 12, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share