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Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds

Primary Purpose

Wounds

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PICO (single use portable negative pressure wound therapy)
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds focused on measuring Chronic, Subacute

Eligibility Criteria

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

Inclusion Criteria:

  • Patients >18 years old
  • Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
  • The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial.
  • Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing.
  • Wound duration ≤52 weeks - Amended to remove criteria.
  • Wound area range ≥5 cm2 at start of screening period
  • Wound maximum linear dimension ≤ 15cm
  • Able to use English for the interview

Exclusion Criteria:

  • Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
  • Wounds which have an infection which is not being treated with systemic antibiotics.
  • Wounds which are actively bleeding.
  • Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
  • Exclude undermining or tunnelling present or suspected in the wound
  • Use of negative pressure device on wound in the last 30 days. Amended to remove criteria
  • Malignant wounds/malignancy in the wound
  • Systemic infection not being treated with systemic antibiotics
  • Simultaneous treatment with other experimental wound care procedures, biologics or devices
  • Patients with a known history of poor compliance with medical treatment.
  • Patients who have participated in this trial previously and who closed or were withdrawn.
  • Patients who are unable to understand the aims and objectives of the trial.

Sites / Locations

  • Nursing Practise Solutions
  • Bradford District Care Trust
  • Papworth Surgery
  • Cossington House Surgery
  • Richmond House Surgery
  • Barton Surgery
  • Derby Hospit6al NHS Foundation Trust
  • South Axholme Practice
  • Sea Road Surgery
  • Dr Moss & Partners
  • The Honiton Group Practise
  • Leodis Care Limited
  • Barlow Medical centre
  • Wellfield Medical Centrre
  • Southbourne Surgery
  • Kiltearn Medical Centre
  • Northumbria Healthcare NHS Trust
  • South Tyneside NHS Foundation Trust
  • Dr Jones & Partners
  • Brunel Medical practise

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PICO

Standard care

Arm Description

PICO Negative Pressure Wound Therapy (NPWT) system

Standard care

Outcomes

Primary Outcome Measures

Time to closure
Time to complete wound closure

Secondary Outcome Measures

Full Information

First Posted
August 18, 2011
Last Updated
February 9, 2018
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02458859
Brief Title
Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds
Official Title
A 100 Patient, Prospective, Randomised, Clinical Evaluation Comparing Clinical and Health Economic Outcomes Between Patients With Chronic or Sub-acute Wounds Treated With Either PICO or Standard Care Dressings and a Qualitative Study to Explore the Experiences of Patients Receiving PICO With Particular Emphasis on Concordance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes.
Detailed Description
The current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with PICO and to explore the patient experience and issues of concordance that affect patients treated with PICO. The study will provide information on the level of clinical benefit that PICO can deliver in the population studied in order to justify a sample size for a definitive evaluation of PICO and the study will further assess wound types that may benefit from treatment with PICO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
Chronic, Subacute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PICO
Arm Type
Active Comparator
Arm Description
PICO Negative Pressure Wound Therapy (NPWT) system
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Device
Intervention Name(s)
PICO (single use portable negative pressure wound therapy)
Intervention Description
Single use portable negative pressure wound therapy
Primary Outcome Measure Information:
Title
Time to closure
Description
Time to complete wound closure
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided. The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial. Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing. Wound duration ≤52 weeks - Amended to remove criteria. Wound area range ≥5 cm2 at start of screening period Wound maximum linear dimension ≤ 15cm Able to use English for the interview Exclusion Criteria: Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing). Wounds which have an infection which is not being treated with systemic antibiotics. Wounds which are actively bleeding. Exposure of blood vessels, organs, bone or tendon at the base of the reference wound Exclude undermining or tunnelling present or suspected in the wound Use of negative pressure device on wound in the last 30 days. Amended to remove criteria Malignant wounds/malignancy in the wound Systemic infection not being treated with systemic antibiotics Simultaneous treatment with other experimental wound care procedures, biologics or devices Patients with a known history of poor compliance with medical treatment. Patients who have participated in this trial previously and who closed or were withdrawn. Patients who are unable to understand the aims and objectives of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Moffatt, Prof
Organizational Affiliation
Royal Derby Hospitals NHS Foundation trust/Nottingham University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursing Practise Solutions
City
Altario
Country
Canada
Facility Name
Bradford District Care Trust
City
Bradford
Country
United Kingdom
Facility Name
Papworth Surgery
City
Cambridge
Country
United Kingdom
Facility Name
Cossington House Surgery
City
Canterbury
Country
United Kingdom
Facility Name
Richmond House Surgery
City
Crook Of Devon
Country
United Kingdom
Facility Name
Barton Surgery
City
Dawlish
Country
United Kingdom
Facility Name
Derby Hospit6al NHS Foundation Trust
City
Derby
Country
United Kingdom
Facility Name
South Axholme Practice
City
Doncaster
Country
United Kingdom
Facility Name
Sea Road Surgery
City
Garway
Country
United Kingdom
Facility Name
Dr Moss & Partners
City
Harrogate
Country
United Kingdom
Facility Name
The Honiton Group Practise
City
Honiton
Country
United Kingdom
Facility Name
Leodis Care Limited
City
Leeds
ZIP/Postal Code
LS17 7PE
Country
United Kingdom
Facility Name
Barlow Medical centre
City
Manchester
Country
United Kingdom
Facility Name
Wellfield Medical Centrre
City
Manchester
Country
United Kingdom
Facility Name
Southbourne Surgery
City
Milton Of Campsie
Country
United Kingdom
Facility Name
Kiltearn Medical Centre
City
Nantwich
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Trust
City
Newcastle
Country
United Kingdom
Facility Name
South Tyneside NHS Foundation Trust
City
Newcastle
Country
United Kingdom
Facility Name
Dr Jones & Partners
City
Sedgefield
Country
United Kingdom
Facility Name
Brunel Medical practise
City
Torquay
Country
United Kingdom

12. IPD Sharing Statement

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Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds

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