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Clinical Evaluation of a Novel Incisional NPWT System

Primary Purpose

Surgical Wound

Status
Recruiting
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
npSIMS
Sponsored by
Aatru Medical LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring incisional NPWT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Middlemore Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

npSIMS

Arm Description

Group will receive the Aatru Medical npSIMS device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Mean (median) days wear time of the adhesive dressing up to day 7
To assess the wear time of the adhesive dressing
Mean (median) days longevity of the chemical vacuum source up to day 7
To assess the longevity of the chemical vacuum source
Presence or absence of blisters on day 7 ±2
Condition of the peri wound skin
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)
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)
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
Frequency of adverse events (non-device related, and device related) up to day30 ±2
To assess the occurrence of adverse events
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
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
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

Full Information

First Posted
July 21, 2020
Last Updated
July 26, 2023
Sponsor
Aatru Medical LLC
Collaborators
NAMSA
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1. Study Identification

Unique Protocol Identification Number
NCT04488666
Brief Title
Clinical Evaluation of a Novel Incisional NPWT System
Official Title
A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aatru Medical LLC
Collaborators
NAMSA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
incisional NPWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
npSIMS
Arm Type
Experimental
Arm Description
Group will receive the Aatru Medical npSIMS device
Intervention Type
Device
Intervention Name(s)
npSIMS
Other Intervention Name(s)
negative pressure Surgical Incision Management system
Intervention Description
incisional NPWT
Primary Outcome Measure Information:
Title
Mean (median) number of days of negative pressure delivered to the incision up to day 7
Description
To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
Description
5 is excellent exudate management; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
Time Frame
7 Days
Title
Mean (median) days wear time of the adhesive dressing up to day 7
Description
To assess the wear time of the adhesive dressing
Time Frame
7 days
Title
Mean (median) days longevity of the chemical vacuum source up to day 7
Description
To assess the longevity of the chemical vacuum source
Time Frame
7 Days
Title
Presence or absence of blisters on day 7 ±2
Description
Condition of the peri wound skin
Time Frame
7 days
Title
Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.
Description
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)
Time Frame
14 days
Title
Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.
Description
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)
Time Frame
30 Days
Title
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.
Description
To assess wound pain daily in the 7 day post-operative period
Time Frame
7 days
Title
Frequency of adverse events (non-device related, and device related) up to day30 ±2
Description
To assess the occurrence of adverse events
Time Frame
30 Days
Title
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
Description
To assess the ease of use by patients assessments
Time Frame
7 days To assess the ease of use by patients assessments
Title
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
Description
To assess the ease of use by clinicians assessments
Time Frame
7 days
Title
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
Description
To assess overall clinician acceptability of the NPWT system
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Martin, PhD
Phone
447736736752
Email
robin@robinmartinphd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Mathy, MD
Organizational Affiliation
1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Middlemore Clinical Trials
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Msiska
Phone
+64 9 276 0044
Ext
56828
Email
kate.msiska@mmclintrials.nz

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of a Novel Incisional NPWT System

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