Status:
COMPLETED
Evaluation of the Use of EZCare/V1STA in the Management of Acute and Chronic Wounds
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this evaluation is to assess the performance of the EZCare/V1STA products, in many different clinical environments, in order to gain a greater insight into the effects of this negative pres...
Detailed Description
Patients meeting the eligibility criteria and agreeing to consent to their participation in the evaluation will receive treatment with the evaluation product for a maximum of 10 dressing changes or up...
Eligibility Criteria
Inclusion
- The patient must be at least 18 years of age
- Males and females - provided they are not pregnant and if of reproductive age are using contraception
- The patient must have an acute or chronic wound deemed suitable for treatment with NPWT
- The patient is able to understand the evaluation and is willing to consent to the evaluation
Exclusion
- Presence of necrotic tissue or \>25% slough in the reference wound. Once debridement has taken place the patient may proceed to enter the evaluation.
- Previously confirmed and untreated osteomyelitis.
- Malignancy in the reference wound bed or margins of the wound.
- Active bleeding in the reference wound. Once haemostasis has been achieved, the patient may proceed to enter the evaluation.
- Exposure of blood vessels or organs at the base of the reference wound.
- Presence of untreated infection in the reference wound. (Infected wounds being treated with systemic antibiotics are permitted)
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this evaluation previously and who healed or were withdrawn
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00994162
Start Date
April 1 2008
End Date
July 1 2009
Last Update
September 21 2022
Active Locations (1)
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1
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655