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

Wounds Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02458859
• Other study ID #: CE/044/PIC
• Status: Terminated
• Phase: N/A
• First received: August 18, 2011
• Last updated: February 9, 2018
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01683344

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Intervention

Device:
• PICO (single use portable negative pressure wound therapy)
Single use portable negative pressure wound therapy

Locations

Country	Name	City	State
Canada	Nursing Practise Solutions	Altario
United Kingdom	Bradford District Care Trust	Bradford
United Kingdom	Papworth Surgery	Cambridge
United Kingdom	Cossington House Surgery	Canterbury
United Kingdom	Richmond House Surgery	Crook Of Devon
United Kingdom	Barton Surgery	Dawlish
United Kingdom	Derby Hospit6al NHS Foundation Trust	Derby
United Kingdom	South Axholme Practice	Doncaster
United Kingdom	Sea Road Surgery	Garway
United Kingdom	Dr Moss & Partners	Harrogate
United Kingdom	The Honiton Group Practise	Honiton
United Kingdom	Leodis Care Limited	Leeds
United Kingdom	Barlow Medical centre	Manchester
United Kingdom	Wellfield Medical Centrre	Manchester
United Kingdom	Southbourne Surgery	Milton Of Campsie
United Kingdom	Kiltearn Medical Centre	Nantwich
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

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to closure	Time to complete wound closure	12 weeks