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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04488666




Registration number
NCT04488666
Ethics application status
Date submitted
21/07/2020
Date registered
28/07/2020
Date last updated
2/11/2023

Titles & IDs
Public title
Clinical Evaluation of a Novel Incisional NPWT System
Scientific title
A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
Secondary ID [1] 0 0
2020-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Wound 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - npSIMS

Experimental: npSIMS - Group will receive the Aatru Medical npSIMS device


Treatment: Devices: npSIMS
incisional NPWT
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean (median) number of days of negative pressure delivered to the incision up to day 7
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
Timepoint [1] 0 0
7 Days
Secondary outcome [2] 0 0
Mean (median) days wear time of the adhesive dressing up to day 7
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Mean (median) days longevity of the chemical vacuum source up to day 7
Timepoint [3] 0 0
7 Days
Secondary outcome [4] 0 0
Presence or absence of blisters on day 7 ±2
Timepoint [4] 0 0
7 days
Secondary outcome [5] 0 0
Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.
Timepoint [6] 0 0
30 Days
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
7 days
Secondary outcome [8] 0 0
Frequency of adverse events (non-device related, and device related) up to day30 ±2
Timepoint [8] 0 0
30 Days
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
7 days To assess the ease of use by patients assessments
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
7 days
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
14 days

Eligibility
Key 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.

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aatru Medical LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NAMSA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04488666
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Mathy, MD
Address 0 0
1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries