Clinical Evaluation of a Novel Incisional NPWT System

NCT04488666 | Completed DMC FDA Device

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Wound

Keywords

incisional NPWT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.

  7 Days

• Mean (median) days wear time of the adhesive dressing up to day 7

  7 days

• Mean (median) days longevity of the chemical vacuum source up to day 7

  7 Days

• Presence or absence of blisters on day 7 ±2

  7 days

• Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.

  14 days

Study Arms (1)

npSIMS

EXPERIMENTAL

Group will receive the Aatru Medical npSIMS device

Device: npSIMS

Interventions

npSIMS DEVICE

incisional NPWT

Also known as: negative pressure Surgical Incision Management system

npSIMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aatru Medical LLC: lead
• NAMSA: collaborator

Study Sites (1)

Middlemore Clinical Trials

Auckland, New Zealand

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jon Mathy, MD

  1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 28, 2020
• Study Start: January 26, 2021
• Primary Completion: August 31, 2023
• Study Completion: June 16, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

NZ (1)