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 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 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: Observational
• Enrollment (Actual): 45
• 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

• 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.

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 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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	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.	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	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	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'.	Up to 14 days
Dressing Wear Time: Closed Incisions Only	Overall dressing wear time in days for Closed Incisions only.	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'.	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.	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	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)?	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').	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.	Screening and Day 28
Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.	Screening and Day 28
Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.	Screening and Day 28
Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: <25% of wound bed covered; 25% to 50% of wound covered; 50% to < 75% of wound covered; 75% to 100% of wound covered	Screening and Day 28
Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: White/grey non-viable tissue; Non-adherent, yellow slough; Loosely adherent, yellow slough; Adherent, soft, black eschar; Firmly adherent, hard/black eschar	Screening and Day 28
Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: Skin intact or partial thickness wound; Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth; Bright, beefy red; < 75% & >25% of wound filled; Pink, &/or dull, dusky red &/or fills <25% of wound; No granulation tissue present	Screening and Day 28
Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: 100% wound covered, surface intact; 75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed; 50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed; 25% to < 50% wound covered; < 25% wound covered	Screening and Day 28
Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.	Screening and Day 28
Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only	Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as: Light; Moderate; Heavy	Screening and Day 28
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	The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply: Normal; Erythematous; Oedematous; Eczematous; Excoriated; Macerated; Indurated; Other	Day 0, Day 7, Day 14, Day 21, and Day 28
Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only	The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.	Day 7, Day 14, Day 21, and Day 28
Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only	The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.	Day 7, Day 14, Day 21, and Day 28
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only	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.	Up to 28 days
Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only	Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: Overall performance; Comfort during wear; Noise level; Discreetness; Portability	Day 14 and Day 28
Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only	Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: Showering; Sleeping; Socializing; Working	Day 14 and Day 28
Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only	Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds 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'.	Up to 28 days
Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only	Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.	Up to 28 days
Dressing Conformability: Chronic and Dehisced Surgical Wounds Only	Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.	Up to 28 days
Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only	Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds	Up to 28 days
Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only	Reason for dressing change for Chronic and Dehisced Surgical Wounds 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	Up to 28 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only	Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?	Day 28

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: Rachel Jahnke, 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 (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• 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; Surgical Wound; Ulcer; Leg Ulcer; Wounds and Injuries; 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