NCT02937909

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

August 31, 2016

Last Update Submit

March 9, 2018

Conditions

Keywords

woundcare community nursing competence

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

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

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 .

Interventions

The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration

Prospective Data

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 24899053BACKGROUND
  • British Broadcasting Corporation 10th Sept 2015 www.bbc.co.uk/news/ accessed 6th Oct 2015

    BACKGROUND
  • Cook L (2011) Assessment: exploring competency and current practice.British Journal of Community Nursing Wound care supplement 16. S34-40

    BACKGROUND
  • Dowsett C (2009) Use of TIME to improve community nurses' wound care knowledge and practice.. Wounds UK, Vol 5 No.3

    BACKGROUND
  • 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.

    PMID: 25375403BACKGROUND
  • 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.

    PMID: 26644123BACKGROUND
  • 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.

    PMID: 16240619BACKGROUND
  • 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.

    PMID: 26198553BACKGROUND
  • Kerr (2014) How best to record and describe wound exudate Wounds UK Vol 10 No 2

    BACKGROUND
  • 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

    BACKGROUND
  • Office for National Statistics (2011) Topic Guide to Older People.

    BACKGROUND
  • Ousey K. Stephenson J et al (2013) Wound Care in five English NHS Trusts: Results of a Survey. Wounds UK Vol 9 No 4

    BACKGROUND
  • 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.

    PMID: 20852568BACKGROUND
  • Wicks G (2012) CQUIN Targets; effective dressing selection. Wound Essentials Vol 7 Issue 2 Nov

    BACKGROUND
  • 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.

    PMID: 12572232BACKGROUND

Study Officials

  • Ray Norris

    North East London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

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

Locations