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

NCT ID: NCT05234632

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2022-09-23

Brief 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.

Conditions

Surgical Incision; Ulcer Foot; Ulcer Venous; Ulcer, Leg; Pressure Ulcer; Wound Dehiscence

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PICO 14 Closed Incisions

Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.

PICO 14 single-use Negative Pressure Wound Therapy System

Intervention Type: DEVICE

The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.

PICO 14 Chronic/Dehisced Surgical Wounds

Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.

PICO 14 single-use Negative Pressure Wound Therapy System

Intervention Type: DEVICE

The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.

Interventions

PICO 14 single-use Negative Pressure Wound Therapy System

The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Jahnke

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

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

Countries

Germany; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PICO14.WND.PRO.2019.03

Identifier Type: -

Identifier Source: org_study_id