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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: PICO 14 single-use Negative Pressure Wound Therapy System


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICO 14 Any Wound<br>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<br>* 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.<br>|
| Experimental: PICO 14 Closed Incisions<br>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<br>* 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.<br>|
| Experimental: PICO 14 Chronic/Dehisced Surgical Wounds<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed incision wounds, Chronic wounds, PICO