Clinical Evaluation of a Novel Incisional NPWT System

Aatru Medical

Status: Completed

Conditions: Surgical Wound

Treatments: Device: npSIMS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04488666

2020-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Participants will undergo post-surgical radiotherapy or chemotherapy
2. Participants who, in the opinion of the Investigator, have an existing health condition that would compromise their participation and follow-up in this study
3. Participant will undergo emergency surgery
4. Participant is sensitive to or known to have allergies to silicone/acrylic adhesives
5. Participant has malignancy in the wound bed or margins of the wound
6. Participant has wound with confirmed and untreated osteomyelitis
7. Participant has wound with non-enteric and unexplored fistulas
8. Participant has wound with necrotic tissue with eschar present
9. Participant has exposed arteries, veins, nerves or organs
10. Participant has exposed anastomotic sites

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

npSIMS

Experimental group

Description:

Group will receive the Aatru Medical npSIMS device

Treatment:

Device: npSIMS