Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds (PICO14)

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

This is a prospective, multi-center, open label study evaluating the performance of PICO14 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 Overview

• Status: Terminated
• Conditions: Surgical Incision; Pressure Ulcer; Ulcer Foot; Wound Dehiscence; Ulcer, Leg; Ulcer Venous
• Intervention / Treatment: Device: PICO 14 single-use Negative Pressure Wound Therapy System

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, D-70374
    • Klinikum der Landeshauptstadt Stuttgart gKAöR
• United Kingdom
  • Margate, United Kingdom
    • Queen Elizabeth the Queen Mother Hospital
  • Newcastle, United Kingdom
    • Northumbria Healthcare NHS Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham Breast Institute
  • Oswestry, United Kingdom, SY10 7AG
    • Robert Jones and Agnes Hunt Orthopaedic Hospital
  • Preston, United Kingdom, PR2 8DW
    • The Lantern Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 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.
• Patients with bleeding disorders, or concomitant use of anticoagulants.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO 14 Any Wound; Any wound treated with PICO 14. For closed Surgical incisions this will be for 14 days post surgery and with a 30 day follow up. 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; 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.
Experimental: 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; 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.
Experimental: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional clinical performance of the PICO14 NPWT system over the treatment period comprised.	Composite Clinical Success will be defined as a binary variable (1/0) - 1 if both the following are true, 0 if either one is false: Nominal pressure is in the interval 80mmHg ±6mmHg. (Delivery of negative pressure will be measured by download of the built-in data chip from the PICO 14 devices.); No exudate leakage. (Occurrence of exudate leaks will be recorded by the clinician.) Composite Clinical Success will be reported as a count and percentage with a 95% CI.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar quality- 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 of both scales can be simply calculated by summing up the scores of each of the six items. The Total Score will therefore range from 6 to 60. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers.	Day 14 and Day 30
Incidence of Surgical Site Infection (SSI) within 30 days of surgery- Closed Incisions Only	Assessment of incision infection will be completed as specified per the CDC definitions of nosocomial surgical site infections at each of the specified time points to identify infection.	Within 30 days of surgery
Incidence of Surgical Site Complication (SSC) within 30 days of surgery: Closed Incisions Only	Incidence of Surgical site Complications (SSC) as applicable: dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess.	Within 30 days of surgery
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days: Closed Incisions Only	The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.	7 days, 14 days, and 30 days
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21, and 28 days: Chronic and Dehisced Surgical Wounds	The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.	7 days, 14 days, 21 days, and 28 days
Ease of application and removal: Chronic and Dehisced Surgical Wounds	Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds to be determined by Yes/No responses to the questions "Was it easy to apply the dressing?" and "Was it easy to remove the dressing?".	28 days
Ease of application and removal: Closed Incisions Only	Ease of application and removal of the PICO 14 dressing for Closed Incisions only to be determined by Yes/No responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing". The frequency of the responses will be calculated.	14 days
Dressing wear time: Chronic and Dehisced Surgical Wounds	Dressing wear time (days) will be summarized as wear time per subject by Chronic and Dehisced Surgical Wounds at 28 days.	28 days
Dressing wear time: Closed Incisions Only	Dressing wear time (days) will be summarized as wear time per subject by Closed Incisions only at 14 days.	14 days
Dressing conformability: Chronic and Dehisced Surgical Wounds Only	Dressing conforms to the wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"	28 days
Dressing conformability: Closed Incisions Only	Dressing conforms to the closed incision wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"	14 days
Dressing change frequency: Chronic and Dehisced Surgical Wounds	Dressing change frequency will be summarized as the number of dressings per subject for Chronic and Dehisced Surgical Wounds	28 days
Dressing change frequency: Closed Incisions Only	Dressing change frequency will be summarized as the number of dressings per subject for Closed Incisions.	30 days
Reason for dressing change: Chronic and Dehisced Surgical Wounds	Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Chronic and Dehisced Surgical Wounds. Frequency of reasons will be summarized.	28 days
Reason for dressing change: Closed Incisions Only	Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Closed Incisions only. Frequency of reasons will be summarized.	30 days
Proportion of patients who said they were satisfied with the product: Chronic and Dehisced Surgical Wounds	Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)	28 days
Proportion of Patients who said they were satisfied with the product: Closed Incisions Only	Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)	14 days
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds	Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.	28 days
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only	Level of pain on 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.	14 days
Percentage change in area of Wound: Chronic and Dehisced Surgical Wounds	The reference wound area will be captured at each study visit. Percentage change in area will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.	7, 14, 21, and 28 days
Percentage change in volume of Wound: Chronic and Dehisced Surgical Wounds	The reference wound volume will be captured at each study visit. Percentage change in volume will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.	7, 14, 21, and 28 days
Incidence of Clinical Infection: Chronic and Dehisced Surgical Wounds	Presence of infection as determined by the clinical signs and symptoms	28 days
Appearance of the Wound as determined by a Modified Bates-Jensen Wound Assessment Tool: Chronic and Dehisced Surgical Wounds	Appearance of the wound will be determined using a Modified Bates-Jensen Wound Assessment Tool for those characteristics measured (wound size, depth, edges, undermining, type of necrotic tissue and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) are each graded on a 5-point scale, with 1 being the best and 5 being the worst.	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of PICO14 in terms of the overall acceptability of the device from the clinician's perspective	Overall acceptability of the device will be determined by the clinician's response to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)? (Yes/No response options).	28 days

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Dr Elizabeth Huddleston, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Chronic wounds; PICO; Closed incision wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Wounds and Injuries; Surgical Wound; Leg Ulcer; Pressure Ulcer
• Other Study ID Numbers: PICO14.WND.PRO.2019.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No