100 Patient study of PICO v Standard care in chronic / sub-acute wounds

Not Applicable

Completed

• Conditions: Chronic and sub acute wounds; Injury, Occupational Diseases, Poisoning; Open wound of unspecified body region

• Registration Number: ISRCTN34166832
• Lead Sponsor: Smith & Nephew Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-10
• Study Completion: 2012-08-25
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients >18 years old
2. Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
3. 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
4. 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
5. Wound duration less than or equal to 52 weeks
6. Wound area range more than or equal to 5 cm2 at start of screening period
7. Wound maximum linear dimension less than or equal to 15cm
8. Able to use English for the interview

Exclusion Criteria

1. 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)
2. Wounds which have an infection which is not being treated with systemic antibiotics
3. Wounds which are actively bleeding
4. Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
5. Exclude undermining or tunnelling present or suspected in the wound
6. Use of negative pressure device on wound in the last 30 days
7. Malignant wounds / malignancy in the wound
8. Systemic infection not being treated with systemic antibiotics
9. Simultaneous treatment with other experimental wound care procedures or devices
10. Patients with a known history of poor compliance with medical treatment
11. Patients who have participated in this trial previously and who closed or were withdrawn
12. Patients who are unable to understand the aims and objectives of the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified