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

February 9, 2018 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

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

  • Canada
      • Altario, Canada
        • Nursing Practise Solutions
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford District Care Trust
      • Cambridge, United Kingdom
        • Papworth Surgery
      • Canterbury, United Kingdom
        • Cossington House Surgery
      • Crook Of Devon, United Kingdom
        • Richmond House Surgery
      • Dawlish, United Kingdom
        • Barton Surgery
      • Derby, United Kingdom
        • Derby Hospit6al NHS Foundation Trust
      • Doncaster, United Kingdom
        • South Axholme Practice
      • Garway, United Kingdom
        • Sea Road Surgery
      • Harrogate, United Kingdom
        • Dr Moss & Partners
      • Honiton, United Kingdom
        • The Honiton Group Practise
      • Leeds, United Kingdom, LS17 7PE
        • Leodis Care Limited
      • Manchester, United Kingdom
        • Barlow Medical Centre
      • Manchester, United Kingdom
        • Wellfield Medical Centrre
      • Milton Of Campsie, United Kingdom
        • Southbourne Surgery
      • Nantwich, United Kingdom
        • Kiltearn Medical Centre
      • Newcastle, United Kingdom
        • Northumbria Healthcare NHS Trust
      • Newcastle, United Kingdom
        • South Tyneside NHS Foundation Trust
      • Sedgefield, United Kingdom
        • Dr Jones & Partners
      • Torquay, United Kingdom
        • Brunel Medical practise

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

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PICO
PICO Negative Pressure Wound Therapy (NPWT) system
Device: PICO (single use portable negative pressure wound therapy)
Single use portable negative pressure wound therapy
NO_INTERVENTION: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to closure
Time Frame: 12 weeks
Time to complete wound closure
12 weeks

Collaborators and Investigators

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

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Christine Moffatt, Prof, Royal Derby Hospitals NHS Foundation trust/Nottingham University

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

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

May 29, 2015

First Posted (ESTIMATE)

June 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE/044/PIC

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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