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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Smith & Nephew Wound Management Inc.
Recruitment status was  Recruiting
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
  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
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: 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 October 30, 2014