Status:
COMPLETED
Clinical Evaluation of a Novel Incisional NPWT System
Lead Sponsor:
Aatru Medical LLC
Collaborating Sponsors:
NAMSA
Conditions:
Surgical Wound
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
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) w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04488666
Start Date
January 26 2021
End Date
June 16 2025
Last Update
July 3 2025
Active Locations (1)
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1
Middlemore Clinical Trials
Auckland, New Zealand