Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
Status: Not yet recruiting

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject has provided written informed consent. Subject is 18 years of age or over. Subject is able and willing to comply with study requirements. Subject is suitable to participate in the study in the opinion of the Investigator. Subject is an inpatient at time of enrollment and will be able to attend follow-up visits in clinic following discharge. Subject has a wound that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device  Exclusion Criteria:  Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study. Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments. For lower extremity wounds, any subject with a wound on a limb with an Ankle Brachial Index (ABI) <0.7 Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria. Subject has had the target wound for greater than three months. Subject has a target wound that measures <3 millimeters (mm) in maximum depth. Subject has untreated osteomyelitis Subject has active, untreated soft tissue infection. Subject has wounds that has previously been managed with NPWT in the previous four (4) weeks Subject has participated previously in this clinical trial. Subject has a history of poor compliance with medical treatment. Pregnancy at time of enrolment. Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study aims to enroll up to 23 subjects from one clinical site in Canada with appropriate wound types including:  Chronic* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause.  As this is a pilot study, there are no limits to inclusion of any one particular wound type, however a minimum of 5 acute and 5 chronic wounds is required. - SamplingMethod: Probability Sample