Clinical trial NCT02458859: 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
Overall status: TERMINATED
Phase: NA
Conditions: Wounds
Keywords: Chronic
Subacute
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to closure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Altario
country: Canada
facility: Nursing Practise Solutions
city: Bradford
country: United Kingdom
facility: Bradford District Care Trust
city: Cambridge
country: United Kingdom
facility: Papworth Surgery
city: Canterbury
country: United Kingdom
facility: Cossington House Surgery
city: Crook Of Devon
country: United Kingdom
facility: Richmond House Surgery
city: Dawlish
country: United Kingdom
facility: Barton Surgery
city: Derby
country: United Kingdom
facility: Derby Hospit6al NHS Foundation Trust
city: Doncaster
country: United Kingdom
facility: South Axholme Practice
city: Garway
country: United Kingdom
facility: Sea Road Surgery
city: Harrogate
country: United Kingdom
facility: Dr Moss & Partners
city: Honiton
country: United Kingdom
facility: The Honiton Group Practise
city: Leeds
country: United Kingdom
facility: Leodis Care Limited
city: Manchester
country: United Kingdom
facility: Barlow Medical centre
city: Manchester
country: United Kingdom
facility: Wellfield Medical Centrre
city: Milton Of Campsie
country: United Kingdom
facility: Southbourne Surgery
city: Nantwich
country: United Kingdom
facility: Kiltearn Medical Centre
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Trust
city: Newcastle
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
city: Sedgefield
country: United Kingdom
facility: Dr Jones & Partners
city: Torquay
country: United Kingdom
facility: Brunel Medical practise
Study officials:
affiliation: Royal Derby Hospitals NHS Foundation trust/Nottingham University
name: Christine Moffatt, Prof
role: PRINCIPAL_INVESTIGATOR
References: