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

This study has been terminated.
(Poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Medical Ltd
ClinicalTrials.gov Identifier:
NCT02458859
First received: August 18, 2011
Last updated: July 7, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention
Wounds
Device: PICO (single use portable negative pressure wound therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Smith & Nephew Medical Ltd:

Primary Outcome Measures:
  • Time to closure [ Time Frame: 12 weeks ]
    Time to complete wound closure


Enrollment: 62
Study Start Date: March 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Standard care

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02458859

Locations
Canada
Nursing Practise Solutions
Ontario, Canada
United Kingdom
Bradford District Care Trust
Bradford, United Kingdom
Papworth Surgery
Cambridge, United Kingdom
Cossington House Surgery
Canterbury, United Kingdom
Kiltearn Medical Centre
Cheshire, United Kingdom
Barton Surgery
Dawlish, United Kingdom
Derby Hospit6al NHS Foundation Trust
Derby, United Kingdom
Richmond House Surgery
Devon, United Kingdom
The Honiton Group Practise
Devon, United Kingdom
South Axholme Practice
Doncaster, United Kingdom
Sea Road Surgery
East Sussex, United Kingdom
Southbourne Surgery
Hampshire, United Kingdom
Dr Moss & Partners
Harrogate, United Kingdom
Leodis Care Limited
Leeds, United Kingdom, LS17 7PE
Barlow Medical centre
Manchester, United Kingdom
Wellfield Medical Centrre
Manchester, United Kingdom
Northumbria Healthcare NHS Trust
Newcastle, United Kingdom
South Tyneside NHS Foundation Trust
Newcastle, United Kingdom
Dr Jones & Partners
Sedgefield, United Kingdom
Brunel Medical practise
Torquay, United Kingdom
Sponsors and Collaborators
Smith & Nephew Medical Ltd
Investigators
Principal Investigator: Christine Moffatt, Prof Royal Derby Hospitals NHS Foundation trust/Nottingham University
  More Information

Responsible Party: Smith & Nephew Medical Ltd
ClinicalTrials.gov Identifier: NCT02458859     History of Changes
Obsolete Identifiers: NCT01683344
Other Study ID Numbers: CE/044/PIC 
Study First Received: August 18, 2011
Last Updated: July 7, 2015

Keywords provided by Smith & Nephew Medical Ltd:
Chronic
Subacute

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on February 24, 2017