Clinical trial NCT04488666: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Wound
Keywords: incisional NPWT
Lead sponsor: Aatru Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2020-07-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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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

Primary outcomes:
measure: Mean (median) number of days of negative pressure delivered to the incision up to day 7
timeFrame: 7 days
Secondary outcomes:
measure: Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
timeFrame: 7 Days
measure: Mean (median) days wear time of the adhesive dressing up to day 7
timeFrame: 7 days
measure: Mean (median) days longevity of the chemical vacuum source up to day 7
timeFrame: 7 Days
measure: Presence or absence of blisters on day 7 ±2
timeFrame: 7 days
measure: Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.
timeFrame: 14 days
measure: Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.
timeFrame: 30 Days
measure: 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.
timeFrame: 7 days
measure: Frequency of adverse events (non-device related, and device related) up to day30 ±2
timeFrame: 30 Days
measure: 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
timeFrame: 7 days To assess the ease of use by patients assessments
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 14 days
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials
Study officials:
affiliation: 1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
name: Jon Mathy, MD
role: PRINCIPAL_INVESTIGATOR
References: