Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds (PICO14)

Smith & Nephew

Status

Terminated

Conditions

Ulcer, Leg

Wound Dehiscence

Pressure Ulcer

Surgical Incision

Ulcer Venous

Ulcer Foot

Treatments

Device: PICO 14 single-use Negative Pressure Wound Therapy System

Study type

Observational

Funder types

Industry

Identifiers

NCT05234632

PICO14.WND.PRO.2019.03

Details and patient eligibility

About

This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.

The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.

Enrollment

45 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject must provide written informed consent.
Subjects eighteen (18) years of age or older.
Willing and able to make all required study visits.
Able to follow instructions.
Subject is suitable to participate in the study in the opinion of the Investigator.

Closed Incisions ONLY:

Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
Any closed surgical incision in a patient in which the patient is deemed high risk of developing surgical site infection (SSI) in the opinion of the investigator.

Chronic wounds ONLY:

Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
- *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.

Dehisced surgical wounds ONLY:

Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
- *Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries

Exclusion criteria

Contraindications (per the PICO 14 Instructions for use [IFU]) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
Subjects who have participated previously in this clinical trial
Subjects with a history of poor compliance with medical treatment.
Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
Pregnancy.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Presence of infection as determined by the clinical signs and symptoms (International wound infection).