Clinical trial NCT05234632: Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
Official title: A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgical Incision
Ulcer Foot
Ulcer Venous
Ulcer, Leg
Pressure Ulcer
Wound Dehiscence
Keywords: Closed incision wounds
Chronic wounds
PICO
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: Delivery of Nominal -80mmHg Negative Pressure
timeFrame: Day 30
measure: Exudate Management: Occurrence of No Exudate Leaks
timeFrame: Up to 30 Days
Secondary outcomes:
measure: Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only
timeFrame: Day 14 and Day 30
measure: Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only
timeFrame: Day 7, Day 14, and Day 30
measure: Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only
timeFrame: Day 7, Day 14, and Day 30
measure: Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only
timeFrame: Day 7, Day 14, and Day 30
measure: Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
timeFrame: Up to 14 Days
measure: Patient Satisfaction During Wear - Performance: Closed Incisions Only
timeFrame: Day 7, Day 14, and Day 30
measure: Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only
timeFrame: Day 7, Day 14, and Day 30
measure: Ease of Application and Removal: Closed Incisions Only
timeFrame: Up to 14 days
measure: Dressing Wear Time: Closed Incisions Only
timeFrame: Up to 14 days
measure: Dressing Conformability: Closed Incisions Only
timeFrame: Up to 14 days
measure: Number of Dressings Used: Closed Incisions Only
timeFrame: Up to 14 days
measure: Reason for Dressing Change: Closed Incisions Only
timeFrame: Up to 14 days
measure: Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only
timeFrame: Day 14
measure: Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 0, Day 7, Day 14, Day 21, and Day 28
measure: Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only
timeFrame: Screening and Day 28
measure: Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 0, Day 7, Day 14, Day 21, and Day 28
measure: Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 7, Day 14, Day 21, and Day 28
measure: Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 7, Day 14, Day 21, and Day 28
measure: Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 14 and Day 28
measure: Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 14 and Day 28
measure: Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Dressing Conformability: Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only
timeFrame: Up to 28 days
measure: Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only
timeFrame: Day 28
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart gKAöR
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham Breast Institute
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Orthopaedic Hospital
city: Preston
country: United Kingdom
facility: The Lantern Centre
Study officials:
affiliation: Smith & Nephew, Inc.
name: Rachel Jahnke
role: STUDY_DIRECTOR
References: