The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.
The study will comprise a prospective, open-labeled, multi-center study to assess the clinical efficacy, functionality and device performance of the new portable negative pressure wound therapy system in the management of acute, sub-acute and chronic wounds. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to ensure minimum numbers in each group for analysis. The primary objective of the study is to determine the time (days) to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
RENASYS TOUCH NPWT System was administered to all participants.
Tiervlei Trail Centre
Bellville, Cape Town, South Africa
Dr Matley & Partners
Claremont, Cape Town, South Africa
The time to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time frame: 28 days
To determine the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time frame: 28 days
To assess the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention, in wounds that are randomized to intermittent or continuous therapy mode
Time frame: 28 days
The percentage change in wound area
To assess progress towards wound closure using the percentage change in wound area (cm2)
Time frame: 28 days
The number of patients with a confirmed clinical infection or presenting with clinical signs of infection
Patients that have a confirmed clinical infection or the number of patients that present with clinical signs of infection in their reference wound
Time frame: 28 days
The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other
To assess the condition of the patients surrounding skin
Time frame: 28 days
To record the patients level of pain using a 10-point pain scale, on application and during therapy, in patient's wounds that are randomised to intermittent or continuous therapy mode
To assess the patients level of pain on application and during therapy
Time frame: 28 days
The study will monitor safety in use and will record and assess all adverse events that occur during the study
Time frame: 28 days
The percentage change in wound volume
To assess progress towards wound closure using the percentage change in wound area (cm3)
Time frame: 28 days
The percentage change in wound depth
To assess progress towards wound closure using the percentage change in wound depth (mm)
Time frame: 28 days
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