A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
The purpose of this investigation is to test the functionality of a novel, non-electric NPWT device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% O2) and hence bring and maintain the system to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical NPWT systems and can be profitably marketed at a discount to the cost of existing commercial devices. The Aatru Medical NPWT system could transform the economics and increase the availability of this therapy across the world.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
incisional NPWT
Middlemore Clinical Trials
Auckland, New Zealand
Mean (median) number of days of negative pressure delivered to the incision up to day 7
To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.
Time frame: 7 days
Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
5 is excellent exudate management; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
Time frame: 7 Days
Mean (median) days wear time of the adhesive dressing up to day 7
To assess the wear time of the adhesive dressing
Time frame: 7 days
Mean (median) days longevity of the chemical vacuum source up to day 7
To assess the longevity of the chemical vacuum source
Time frame: 7 Days
Presence or absence of blisters on day 7 ±2
Condition of the peri wound skin
Time frame: 7 days
Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.
To assess the appearance of the closed incision and scar. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation)
Time frame: 14 days
Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.
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Assess the Frequency of Surgical site infections. A higher ASEPSIS score indicates impaired wound healing (a score of \>10 indicates an increasing probability and severity of infection)
Time frame: 30 Days
Mean (median) wound pain score using a 0 -10 NRS (numerical rating score) by the study participant each day up to day 7±2. 10 is worst imaginable pain; 0 is no pain.
To assess wound pain daily in the 7 day post-operative period
Time frame: 7 days
Frequency of adverse events (non-device related, and device related) up to day30 ±2
To assess the occurrence of adverse events
Time frame: 30 Days
Mean (median) ease of use score from patients on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
To assess the ease of use by patients assessments
Time frame: 7 days To assess the ease of use by patients assessments
Mean (median) ease of use score from clinicians on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
To assess the ease of use by clinicians assessments
Time frame: 7 days
Mean (median) score of overall clinician acceptability of the NPWT system (pump & dressing) on 5-point NRS assessed at day 14 ±2. 5 is Excellent incision management system; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
To assess overall clinician acceptability of the NPWT system
Time frame: 14 days