Clinical Evaluation of a Novel Incisional NPWT System

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: npSIMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Participant is male or female ≥ 18 years of age 2. Participant will undergo an elective sternotomy, thoracotomy, caesarean section (C-section) or skin surgery incision with closure by sutures or staples 3. Participant will undergo a surgical procedure resulting in a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that the npSIMS dressing covers the wound with a minimum of 1 cm overlap at each end 4. Participant is willing and able to take part in the study and provide written informed consent. - Exclusion Criteria: Participants will undergo post-surgical radiotherapy or chemotherapy Participants who, in the opinion of the Investigator, have an existing health condition that would compromise their participation and follow-up in this study Participant will undergo emergency surgery Participant is sensitive to or known to have allergies to silicone/acrylic adhesives Participant has malignancy in the wound bed or margins of the wound Participant has wound with confirmed and untreated osteomyelitis Participant has wound with non-enteric and unexplored fistulas Participant has wound with necrotic tissue with eschar present Participant has exposed arteries, veins, nerves or organs Participant has exposed anastomotic sites

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: npSIMS<br>Group will receive the Aatru Medical npSIMS device | Device: npSIMS<br>* incisional NPWT<br>* Other names: negative pressure Surgical Incision Management system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 Days | 
| Mean (median) days wear time of the adhesive dressing up to day 7 | To assess the wear time of the adhesive dressing | 7 days | 
| Mean (median) days longevity of the chemical vacuum source up to day 7 | To assess the longevity of the chemical vacuum source | 7 Days | 
| Presence or absence of blisters on day 7 ±2 | Condition of the peri wound skin | 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) | 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. | 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) | 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 | 7 days | 
| Frequency of adverse events (non-device related, and device related) up to day30 ±2 | To assess the occurrence of adverse events | 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 | 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 | 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 | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incisional NPWT