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

Primary Purpose

Wound - in Medical Care

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Use of wound care products from a single manufacturer
Sponsored by
BSN Medical Ltd. UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wound - in Medical Care focused on measuring woundcare community nursing competence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective Data

Historical data

Arm Description

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

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with wounds treated
Wound types treated
Total number of wound closure occurred
Average duration of treatment
Patients Quality of Life living with a Wound
as measured by use of the validated questionnaire Wound QoL.
Confidence of healthcare professionals in their dressing selection
as measured by written assessment
Visual Analogue Scoring by the healthcare professionals of the simplification of training
Time required for training
NHS Trainer's time
NHS Trainer's cost
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
Costs of dressings used
Number of wounds which could not be treated by the integrated range
Condition of wounds which could not be treated by the integrated range

Full Information

First Posted
August 31, 2016
Last Updated
March 9, 2018
Sponsor
BSN Medical Ltd. UK
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1. Study Identification

Unique Protocol Identification Number
NCT02937909
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to Inadequate patient recruitment
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BSN Medical Ltd. UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound - in Medical Care
Keywords
woundcare community nursing competence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Data
Arm Type
Experimental
Arm Description
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
Arm Title
Historical data
Arm Type
No Intervention
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Use of wound care products from a single manufacturer
Intervention Description
The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration
Primary Outcome Measure Information:
Title
Incidence of inappropriate use of dressings for the wound condition and patient lifestyle
Description
As measured by referrals for case review to the Tissue Viability Team during the study
Time Frame
At the end of 12 weeks treatment period
Secondary Outcome Measure Information:
Title
Number of patients with wounds treated
Time Frame
At the end of 12 weeks treatment period
Title
Wound types treated
Time Frame
At the end of 12 weeks treatment period
Title
Total number of wound closure occurred
Time Frame
At the end of 12 weeks treatment period
Title
Average duration of treatment
Time Frame
At the end of 12 weeks treatment period
Title
Patients Quality of Life living with a Wound
Description
as measured by use of the validated questionnaire Wound QoL.
Time Frame
At the start of the study and at the end of 12 weeks treatment period
Title
Confidence of healthcare professionals in their dressing selection
Description
as measured by written assessment
Time Frame
At the start of the study and at the end of 12 weeks treatment period
Title
Visual Analogue Scoring by the healthcare professionals of the simplification of training
Time Frame
At the end of 12 weeks treatment period
Title
Time required for training
Time Frame
At the end of 12 weeks treatment period
Title
NHS Trainer's time
Time Frame
At the end of 12 weeks treatment period
Title
NHS Trainer's cost
Time Frame
At the end of 12 weeks treatment period
Title
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
Title
Costs of dressings used
Time Frame
At the end of 12 weeks treatment period
Title
Number of wounds which could not be treated by the integrated range
Time Frame
At the end of 12 weeks treatment period
Title
Condition of wounds which could not be treated by the integrated range
Time Frame
At the end of 12 weeks treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Norris
Organizational Affiliation
North East London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital
City
Brentwood
State/Province
Essex
ZIP/Postal Code
CM15 8DR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24899053
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.
Results Reference
background
Citation
British Broadcasting Corporation 10th Sept 2015 www.bbc.co.uk/news/ accessed 6th Oct 2015
Results Reference
background
Citation
Cook L (2011) Assessment: exploring competency and current practice.British Journal of Community Nursing Wound care supplement 16. S34-40
Results Reference
background
Citation
Dowsett C (2009) Use of TIME to improve community nurses' wound care knowledge and practice.. Wounds UK, Vol 5 No.3
Results Reference
background
PubMed Identifier
25375403
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.
Results Reference
background
PubMed Identifier
26644123
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.
Results Reference
background
PubMed Identifier
16240619
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.
Results Reference
background
PubMed Identifier
26198553
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.
Results Reference
background
Citation
Kerr (2014) How best to record and describe wound exudate Wounds UK Vol 10 No 2
Results Reference
background
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
Results Reference
background
Citation
Office for National Statistics (2011) Topic Guide to Older People.
Results Reference
background
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
Results Reference
background
PubMed Identifier
20852568
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.
Results Reference
background
Citation
Wicks G (2012) CQUIN Targets; effective dressing selection. Wound Essentials Vol 7 Issue 2 Nov
Results Reference
background
PubMed Identifier
12572232
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.
Results Reference
background

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

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