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

Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02458859
Collaborator
(none)
62
Enrollment
20
Locations
2
Arms
39
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PICO (single use portable negative pressure wound therapy)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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 and a Qualitative Study to Explore the Experiences of Patients Receiving PICO With Particular Emphasis on Concordance
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PICO

PICO Negative Pressure Wound Therapy (NPWT) system

Device: PICO (single use portable negative pressure wound therapy)
Single use portable negative pressure wound therapy
No Intervention: Standard care

Standard care

Outcome Measures

Primary Outcome Measures

  1. Time to closure [12 weeks]

    Time to complete wound closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nursing Practise Solutions Altario Canada
2 Bradford District Care Trust Bradford United Kingdom
3 Papworth Surgery Cambridge United Kingdom
4 Cossington House Surgery Canterbury United Kingdom
5 Richmond House Surgery Crook Of Devon United Kingdom
6 Barton Surgery Dawlish United Kingdom
7 Derby Hospit6al NHS Foundation Trust Derby United Kingdom
8 South Axholme Practice Doncaster United Kingdom
9 Sea Road Surgery Garway United Kingdom
10 Dr Moss & Partners Harrogate United Kingdom
11 The Honiton Group Practise Honiton United Kingdom
12 Leodis Care Limited Leeds United Kingdom LS17 7PE
13 Barlow Medical centre Manchester United Kingdom
14 Wellfield Medical Centrre Manchester United Kingdom
15 Southbourne Surgery Milton Of Campsie United Kingdom
16 Kiltearn Medical Centre Nantwich United Kingdom
17 Northumbria Healthcare NHS Trust Newcastle United Kingdom
18 South Tyneside NHS Foundation Trust Newcastle United Kingdom
19 Dr Jones & Partners Sedgefield United Kingdom
20 Brunel Medical practise Torquay United Kingdom

Sponsors and Collaborators

  • Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Christine Moffatt, Prof, Royal Derby Hospitals NHS Foundation trust/Nottingham University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT02458859
Other Study ID Numbers:
  • CE/044/PIC
  • NCT01683344
First Posted:
Jun 1, 2015
Last Update Posted:
Feb 13, 2018
Last Verified:
Feb 1, 2018
Keywords provided by Smith & Nephew, Inc.
Chronic
Subacute
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Feb 13, 2018