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Clinical and Health Economic Study of PICO in a Community Care Setting

This study is currently recruiting participants.
Verified September 2012 by Smith & Nephew Wound Management Inc
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier:
NCT01683344
First received: September 7, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Wounds
 Device: PICO
Other: Standard Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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

Further study details as provided by Smith & Nephew Wound Management Inc:

Primary Outcome Measures:
  • Difference in time to wound closure. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    To assess the difference in time to closure for chronic and sub-acute wounds between PICO and standard care.


Secondary Outcome Measures:
  • Difference in reduction in wound area. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    To assess the difference in the reduction in wound area for chronic and sub-acute wounds between PICO and standard care.

  • Difference in reduction in wound depth. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    To assess the difference in the reduction in wound depth for chronic and sub-acute wounds between PICO and standard care

  • Difference in reduction in wound volume. [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    To assess the difference in the reduction in wound volume for chronic and sub-acute wounds between PICO and standard care

  • Difference in the cost of treatment between PICO and standard care dressings [ Time Frame: Baseline to 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PICO NPWT
PICO* Single-Use Negative Pressure Wound Therapy (Smith & Nephew Wound Management Inc)
 Device: PICO
Negative-Pressure Wound Therapy
Standard Care
Standard of care dressings
 Other: Standard Care
Standard care dressings

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683344

Contacts
Contact: Kate Drysdale +44 1482 673405 kate.drysdale@smith-nephew.com
Contact: Emma Whatley +44 1482 673648 Emma.Whatley@smith-nephew.com

Locations
United Kingdom
The Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Sponsors and Collaborators
Smith & Nephew Wound Management Inc
Investigators
Principal Investigator: Christine Moffatt, Professor The Royal Derby Hospital
  More Information

No publications provided

Responsible Party: Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier: NCT01683344     History of Changes
Other Study ID Numbers: CE044PIC
Study First Received: September 7, 2012
Last Updated: September 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Smith & Nephew Wound Management Inc:
chronic, sub-acute wounds

ClinicalTrials.gov processed this record on May 23, 2013