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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05234632

Acronym

PICO14

Enrollment

Registered

2022-02-10

Start date

2020-09-22

Completion date

2022-09-23

Last updated

2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Closed incision wounds, Chronic wounds, PICO

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.

Interventions

DEVICEPICO 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Delivery of Nominal -80mmHg Negative Pressure	Day 30	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.
Exudate Management: Occurrence of No Exudate Leaks	Up to 30 Days	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.

Secondary

Measure	Time frame	Description
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only	Day 7, Day 14, and Day 30	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).
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only	Day 7, Day 14, and Day 30	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
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only	Up to 14 Days	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.
Patient Satisfaction During Wear - Performance: Closed Incisions Only	Day 7, Day 14, and Day 30	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
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only	Day 7, Day 14, and Day 30	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
Ease of Application and Removal: Closed Incisions Only	Up to 14 days	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'.
Dressing Wear Time: Closed Incisions Only	Up to 14 days	Overall dressing wear time in days for Closed Incisions only.
Dressing Conformability: Closed Incisions Only	Up to 14 days	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'.
Number of Dressings Used: Closed Incisions Only	Up to 14 days	Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.
Reason for Dressing Change: Closed Incisions Only	Up to 14 days	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
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only	Day 14	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)?
Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only	Day 0, Day 7, Day 14, Day 21, and Day 28	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').
Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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.
Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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.
Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only	Day 14 and Day 30	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.
Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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
Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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
Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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.
Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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
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	Day 0, Day 7, Day 14, Day 21, and Day 28	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
Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only	Day 7, Day 14, Day 21, and Day 28	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.
Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only	Day 7, Day 14, Day 21, and Day 28	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.
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only	Up to 28 days	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.
Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only	Day 14 and Day 28	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
Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only	Day 14 and Day 28	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
Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only	Up to 28 days	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'.
Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only	Up to 28 days	Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.
Dressing Conformability: Chronic and Dehisced Surgical Wounds Only	Up to 28 days	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'.
Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only	Up to 28 days	Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds
Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only	Up to 28 days	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
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only	Day 28	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)?
Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only	Screening and Day 28	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
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only	Day 7, Day 14, and Day 30	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).

Countries

Germany, United Kingdom

Participant flow

Pre-assignment details

Overall, 45 participants were enrolled to the study at 6 sites. There was one (1) screen failure, leaving 44 subjects (25 closed incisions; 19 chronic wounds) receiving PICO 14 NPWT treatment forming the safety analysis set (SAF).

Participants by arm

Arm	Count
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. 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.	25
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. 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.	19
Total	44

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	4
Overall Study	Participant tested positive for COVID-19 and is in isolation	0	1
Overall Study	Participant Withdrawn: Non-Compliance	1	0
Overall Study	Physician Decision	1	1
Overall Study	Withdrawal by Subject	2	0
Overall Study	Withdrawn by participant upon experiencing Adverse Event.	1	0

Baseline characteristics

Characteristic	PICO 14 Closed Incisions	PICO 14 Chronic/Dehisced Surgical Wounds	Total
Age, Continuous	71.6 years STANDARD_DEVIATION 10.2	71.3 years STANDARD_DEVIATION 16.3	71.5 years STANDARD_DEVIATION 13
Body Mass Index (BMI)	29.1 kg/m^2 STANDARD_DEVIATION 4.6	30.0 kg/m^2 STANDARD_DEVIATION 9.8	29.5 kg/m^2 STANDARD_DEVIATION 7.1
Race/Ethnicity, Customized Race Asian	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Black	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Caucasian	25 Participants	15 Participants	40 Participants
Race/Ethnicity, Customized Race Other	0 Participants	4 Participants	4 Participants
Region of Enrollment Germany	0 participants	3 participants	3 participants
Region of Enrollment United Kingdom	25 participants	16 participants	41 participants
Sex: Female, Male Female	16 Participants	13 Participants	29 Participants
Sex: Female, Male Male	9 Participants	6 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	1 / 19
other Total, other adverse events	21 / 25	11 / 19
serious Total, serious adverse events	1 / 25	3 / 19

Outcome results

Primary

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

Population: Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.

Arm	Measure	Value (MEAN)	Dispersion
PICO 14 Closed Incisions	Delivery of Nominal -80mmHg Negative Pressure	-77.2 millimeters of mercury (mmHg)	Standard Deviation 7.7
PICO 14 Chronic/Dehisced Surgical Wounds	Delivery of Nominal -80mmHg Negative Pressure	-74.7 millimeters of mercury (mmHg)	Standard Deviation 11.4
PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds)	Delivery of Nominal -80mmHg Negative Pressure	-76.2 millimeters of mercury (mmHg)	Standard Deviation 9.3

Primary

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

Population: Full Analysis Set (FAS) population included all participants recruited into the study that attended at least one post-baseline assessment with available data at the time frame indicated.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
PICO 14 Closed Incisions	Exudate Management: Occurrence of No Exudate Leaks	13 Participants
PICO 14 Chronic/Dehisced Surgical Wounds	Exudate Management: Occurrence of No Exudate Leaks	8 Participants
PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds)	Exudate Management: Occurrence of No Exudate Leaks	21 Participants

Secondary

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.