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

Wound - in Medical Care Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02937909
• Other study ID #: WMC 75/UK/15
• Status: Terminated
• Phase: N/A
• First received: August 31, 2016
• Last updated: March 9, 2018
• Start date: February 15, 2017
• Est. completion date: December 6, 2017

Study information

• Verified date: March 2018
• Source: BSN Medical Ltd. UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 6, 2017
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound - in Medical Care
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United Kingdom	South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital	Brentwood	Essex

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical Ltd. UK

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with wounds treated		At the end of 12 weeks treatment period
Secondary	Wound types treated		At the end of 12 weeks treatment period
Secondary	Total number of wound closure occurred		At the end of 12 weeks treatment period
Secondary	Average duration of treatment		At the end of 12 weeks treatment period
Secondary	Patients Quality of Life living with a Wound	as measured by use of the validated questionnaire Wound QoL.	At the start of the study and at the end of 12 weeks treatment period
Secondary	Confidence of healthcare professionals in their dressing selection	as measured by written assessment	At the start of the study and at the end of 12 weeks treatment period
Secondary	Visual Analogue Scoring by the healthcare professionals of the simplification of training		At the end of 12 weeks treatment period
Secondary	Time required for training		At the end of 12 weeks treatment period
Secondary	NHS Trainer's time		At the end of 12 weeks treatment period
Secondary	NHS Trainer's cost		At the end of 12 weeks treatment period
Secondary	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		At the end of 12 weeks treatment period
Secondary	Costs of dressings used		At the end of 12 weeks treatment period
Secondary	Number of wounds which could not be treated by the integrated range		At the end of 12 weeks treatment period
Secondary	Condition of wounds which could not be treated by the integrated range		At the end of 12 weeks treatment period