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

March 9, 2018 updated by: BSN Medical Ltd. UK

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Brentwood, Essex, United Kingdom, CM15 8DR
        • South West Essex Community Services, North East London NHS Foundation Trust, Brentwood Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective Data
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
The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration
No Intervention: Historical data
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of inappropriate use of dressings for the wound condition and patient lifestyle
Time Frame: At the end of 12 weeks treatment period
As measured by referrals for case review to the Tissue Viability Team during the study
At the end of 12 weeks treatment period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BSN Medical Ltd. UK

Investigators

  • Principal Investigator: Ray Norris, North East London NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

December 6, 2017

Study Completion (Actual)

December 6, 2017

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMC 75/UK/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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