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Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds | Clinical Trials | Clareo Health

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

A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds

NCT05234632•Smith & Nephew, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+4 more criteria

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.
+1 more criteria

Locations (6)

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

Northumbria Healthcare NHS Trust

Newcastle, United Kingdom

Nottingham Breast Institute

Nottingham, United Kingdom

Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, United Kingdom

The Lantern Centre

Preston, United Kingdom

Key Dates

Start Date

September 22, 2020

Primary Completion Date

September 23, 2022

Completion Date

September 23, 2022

Last Updated

June 6, 2025

Enrollment

ACTUAL participants

Conditions

Surgical IncisionUlcer FootUlcer VenousUlcer, LegPressure UlcerWound Dehiscence

Interventions

PICO 14 single-use Negative Pressure Wound Therapy System

DEVICE

Zinc Oxide Versus Petrolatum Following Skin Surgery

NCT03561376

Surgical IncisionSurgery--Complications+4 more

View study

RECRUITINGPHASE4

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT07086443

Diabetic Foot UlcerDFU+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Zinc Oxide Versus Petrolatum Following Skin Surgery

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in Patients Who Have Undergone Thyroid and Parathyroid Surgery Via the Transcutaneous Approach

Transcutaneous CO₂ Therapy in Recurrent Hard-to-Heal Diabetic Foot Ulcers

Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions

Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers