CompletedNot Applicable

Clinical Evaluation of a Novel Incisional NPWT System

New Zealand23 participantsStarted 2021-01-26

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Mean (median) number of days of negative pressure delivered to the incision up to day 7

Timeframe: 7 days

Trial details

NCT IDNCT04488666

SponsorAatru Medical LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Surgical Wound trials