Surgical WoundNCT04488666
Clinical Evaluation of a Novel Incisional NPWT System
A study testing npSIMS in people with Surgical Wound, run by Aatru Medical LLC at 1 site in New Zealand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound
- What is being tested?
- npSIMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNew Zealand
- Study dates
- 26 Jan 2021to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
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
Read the 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) 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.
- Conditions
- Surgical Wound
- Being tested
- npSIMS
- Keywords
- incisional NPWT
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
npSIMSDevice
Also called negative pressure Surgical Incision Management system
incisional NPWT
| Study group | Role | What they receive |
|---|---|---|
| npSIMS | Experimental | Group will receive the Aatru Medical npSIMS device Receives: Device: npSIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
5 is excellent exudate management; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
Measured: 7 Days
Mean (median) days wear time of the adhesive dressing up to day 7
To assess the wear time of the adhesive dressing
Measured: 7 days
Mean (median) days longevity of the chemical vacuum source up to day 7
To assess the longevity of the chemical vacuum source
Measured: 7 Days
Presence or absence of blisters on day 7 ±2
Condition of the peri wound skin
Measured: 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)
Measured: 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)
Measured: 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
Measured: 7 days
Frequency of adverse events (non-device related, and device related) up to day30 ±2
To assess the occurrence of adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start26 Jan 2021
- Primary completion31 Aug 2023
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aatru Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Jon Mathy, MD, Principal investigator, 1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488666
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
- ClinicalTrials.gov ID
- NCT04488666
- Acronym / sponsor ID
- 2020-01
- Conditions
- Surgical Wound
- Keywords
- incisional NPWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Aatru Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| npSIMS | Experimental | Device: npSIMSGroup will receive the Aatru Medical npSIMS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| npSIMSAlso: negative pressure Surgical Incision Management systemincisional NPWT | Device | npSIMS |
Primary outcome
Mean (median) number of days of negative pressure delivered to the incision up to day 7
Time frame: 7 days
To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.
11 secondary outcomes
Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
Time frame: 7 Days
Mean (median) days wear time of the adhesive dressing up to day 7
Time frame: 7 days
Mean (median) days longevity of the chemical vacuum source up to day 7
Time frame: 7 Days
Presence or absence of blisters on day 7 ±2
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.
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.
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.
Time frame: 7 days
Frequency of adverse events (non-device related, and device related) up to day30 ±2
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
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
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
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Mathy, MD principal investigator
1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing npSIMS in people with Surgical Wound, run by Aatru Medical LLC at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (median) number of days of negative pressure delivered to the incision up to day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.