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

NCT05234632 | Terminated Results

• 1 other identifier: PICO14.WND.PRO.2019.03
• Study Type: observational
• Target: 45
• Locations: 2 countries
• Sites: 6

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

Keywords

Closed incision wounds; Chronic wounds; PICO

Outcome Measures

Primary Outcomes (2)

• Delivery of Nominal -80mmHg Negative Pressure

  Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.

  Day 30

• Exudate Management: Occurrence of No Exudate Leaks

  Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.

  Up to 30 Days

Secondary Outcomes (35)

• Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only

  Day 14 and Day 30

• Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only

  Day 7, Day 14, and Day 30

• Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only

  Day 7, Day 14, and Day 30

• Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only

  Day 7, Day 14, and Day 30

• Level of Pain - Visual Analog Score (VAS): Closed Incisions Only

  Up to 14 Days

Study Arms (2)

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.

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

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.

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

Interventions

PICO 14 single-use Negative Pressure Wound Therapy System 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; PICO 14 Closed Incisions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical wounds and post-operative incisions. The patients will be recruited from up to 7 sites in the United Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, D-70374, Germany

Location

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

Location

Northumbria Healthcare NHS Trust

Newcastle, United Kingdom

Location

Nottingham Breast Institute

Nottingham, NG5 1PB, United Kingdom

Location

Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, SY10 7AG, United Kingdom

Location

The Lantern Centre

Preston, PR2 8DW, United Kingdom

Location

MeSH Terms

Conditions

Surgical Wound; Foot Ulcer; Varicose Ulcer; Leg Ulcer; Pressure Ulcer

Condition Hierarchy (Ancestors)

Wounds and Injuries; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Ulcer; Varicose Veins; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Rochelle O'Hara
• Organization: Smith & Nephew, Inc.

Rochelle.OHara@smith-nephew.com

+44 1923 477218

Study Officials

• Rachel Jahnke

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: February 10, 2022
• Study Start: September 22, 2020
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: June 6, 2025
• Results First Posted: January 28, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); DE (1)