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

Smith & Nephew, Inc.45 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 30 Days

Secondary Outcomes

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

The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the evaluation of all types of scars by professionals and patients. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable. The Total Score is provided for both the Patient Scale and Observer Scale at Day 14 \& Day 30. The Total Score for both scales was calculated by summing up the scores of each of the six items. The Total Score ranged from 6 to 60 with a lower score indicating a better outcome.

Time frame: Day 14 and Day 30

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

Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No).

Time frame: Day 7, Day 14, and Day 30

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

Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No).

Time frame: 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

The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply: * Healthy * Fragile * Inflamed * Erythematous * Oedematous * Eczematous * Macerated * Bruising * Dry and flaky * Other

Time frame: Day 7, Day 14, and Day 30

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

Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.

Time frame: Up to 14 Days

Patient Satisfaction During Wear - Performance: Closed Incisions Only

Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Overall performance * Comfort during wear * Noise level * Discreetness * Portability

Time frame: Day 7, Day 14, and Day 30

Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only

Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Showering * Sleeping * Socializing * Working

Time frame: Day 7, Day 14, and Day 30

Ease of Application and Removal: Closed Incisions Only

Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.

Time frame: Up to 14 days

Dressing Wear Time: Closed Incisions Only

Overall dressing wear time in days for Closed Incisions only.

Time frame: Up to 14 days

Dressing Conformability: Closed Incisions Only

Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.

Time frame: Up to 14 days

Number of Dressings Used: Closed Incisions Only

Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.

Time frame: Up to 14 days

Reason for Dressing Change: Closed Incisions Only

Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No': * Routine dressing change * Inadequate exudate management * Pain/discomfort * Dressing damaged * Dressing fell off * Patient removed dressing * Adverse Event * Surgical procedure * Safety alarm * Dressing components not in place * No vacuum * other

Time frame: Up to 14 days

Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only

Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?

Time frame: Day 14

Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only

Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No').

Time frame: Day 0, Day 7, Day 14, Day 21, and Day 28

Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only

Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.