Clinical Evaluation of a Novel Incisional NPWT System

Surgical Wound Clinical Trial

Official title:

A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04488666
• Other study ID #: 2020-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Aatru Medical LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: February 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• npSIMS
incisional NPWT

Locations

Country	Name	City	State
New Zealand	Middlemore Clinical Trials	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Aatru Medical LLC	NAMSA

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	7 Days
Secondary	Mean (median) days wear time of the adhesive dressing up to day 7	To assess the wear time of the adhesive dressing	7 days
Secondary	Mean (median) days longevity of the chemical vacuum source up to day 7	To assess the longevity of the chemical vacuum source	7 Days
Secondary	Presence or absence of blisters on day 7 ±2	Condition of the peri wound skin	7 days
Secondary	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)	14 days
Secondary	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)	30 Days
Secondary	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	7 days
Secondary	Frequency of adverse events (non-device related, and device related) up to day30 ±2	To assess the occurrence of adverse events	30 Days
Secondary	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	7 days To assess the ease of use by patients assessments
Secondary	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	7 days
Secondary	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	14 days