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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01683344
• Other study ID #: CE044PIC
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2012
• Last updated: September 11, 2012
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: Smith & Nephew Wound Management Inc
• Contact: Kate Drysdale
• Phone: +44 1482 673405
• Email: kate.drysdale[@]smith-nephew.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• PICO
Negative-Pressure Wound Therapy

Other:
• Standard Care
Standard care dressings

Locations

Country	Name	City	State
United Kingdom	The Royal Derby Hospital	Derby

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Wound Management Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in time to wound closure.	To assess the difference in time to closure for chronic and sub-acute wounds between PICO and standard care.	Baseline to 12 weeks	No
Secondary	Difference in reduction in wound area.	To assess the difference in the reduction in wound area for chronic and sub-acute wounds between PICO and standard care.	Baseline to 12 weeks	No
Secondary	Difference in reduction in wound depth.	To assess the difference in the reduction in wound depth for chronic and sub-acute wounds between PICO and standard care	Baseline to 12 weeks	No
Secondary	Difference in reduction in wound volume.	To assess the difference in the reduction in wound volume for chronic and sub-acute wounds between PICO and standard care	Baseline to 12 weeks	No
Secondary	Difference in the cost of treatment between PICO and standard care dressings		Baseline to 7 days	No