Trial Outcomes & Findings for Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds (NCT NCT05234632)

Last Updated: 2025-06-06

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

45 participants

Primary outcome timeframe

Day 30

Results posted on

2025-06-06

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	25	19
Overall Study COMPLETED	20	13
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

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Overall Study Participant Withdrawn: Non-Compliance	1	0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Overall Study Withdrawn by participant upon experiencing Adverse Event.	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PICO 14 Closed Incisions n=25 Participants 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.	PICO 14 Chronic/Dehisced Surgical Wounds n=19 Participants 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.	Total n=44 Participants Total of all reporting groups
Age, Continuous	71.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	71.3 years STANDARD_DEVIATION 16.3 • n=7 Participants	71.5 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United Kingdom	25 participants n=5 Participants	16 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment Germany	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Body Mass Index (BMI)	29.1 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	30.0 kg/m^2 STANDARD_DEVIATION 9.8 • n=7 Participants	29.5 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=18 Participants 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.	PICO 14 Chronic/Dehisced Surgical Wounds n=13 Participants 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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) n=31 Participants 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. 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.
Delivery of Nominal -80mmHg Negative Pressure	-77.2 millimeters of mercury (mmHg) Standard Deviation 7.7	-74.7 millimeters of mercury (mmHg) Standard Deviation 11.4	-76.2 millimeters of mercury (mmHg) Standard Deviation 9.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=20 Participants 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.	PICO 14 Chronic/Dehisced Surgical Wounds n=13 Participants 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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) n=33 Participants 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. 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.
Exudate Management: Occurrence of No Exudate Leaks	13 Participants	8 Participants	21 Participants

SECONDARY outcome

Timeframe: Day 14 and 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.

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.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=20 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only Day 14: Patient Scale Total Score	18.9 score on a scale Standard Deviation 11.9	—	—
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only Day 14: Observer Scale Total Score	16.3 score on a scale Standard Deviation 9	—	—
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only Day 30: Patient Scale Total Score	19.5 score on a scale Standard Deviation 10.6	—	—
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only Day 30: Observer Scale Total Score	13.7 score on a scale Standard Deviation 7.4	—	—

SECONDARY outcome

Timeframe: Day 7, Day 14, and 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. The FAS population for this outcome measure includes only participants with Closed Incisions identified as not healed (i.e., not fully closed/epithelialized).

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).

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=8 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 7: Is Incision Clinically Infected · Yes	0 Participants	—	—
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 7: Is Incision Clinically Infected · No	8 Participants	—	—
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 14: Is Incision Clinically Infected · Yes	2 Participants	—	—
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 14: Is Incision Clinically Infected · No	0 Participants	—	—
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 30: Is Incision Clinically Infected · Yes	0 Participants	—	—
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only Day 30: Is Incision Clinically Infected · No	2 Participants	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=8 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 7: Incision Dehisced · Yes	0 Participants	—	—
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 7: Incision Dehisced · No	8 Participants	—	—
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 14: Incision Dehisced · Yes	1 Participants	—	—
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 14: Incision Dehisced · No	1 Participants	—	—
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 30: Incision Dehisced · Yes	1 Participants	—	—
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only Day 30: Incision Dehisced · No	1 Participants	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=22 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Other	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Healthy	20 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Healthy	18 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Fragile	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Inflamed	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Erythematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Oedematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Eczematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Macerated	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Bruising	11 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Dry and flaky	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 7: Other	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Healthy	15 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Fragile	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Inflamed	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Erythematous	2 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Oedematous	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Eczematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Macerated	2 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Bruising	4 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 14: Dry and flaky	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Fragile	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Inflamed	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Erythematous	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Oedematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Eczematous	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Macerated	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Bruising	0 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Dry and flaky	1 Participants	—	—
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only Day 30: Other	0 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=47 Dressings 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only Level of Pain: Dressing Application	0.5 score on a scale Standard Deviation 1.3	—	—
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only Level of Pain: During Wear	2.5 score on a scale Standard Deviation 2.5	—	—
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only Level of Pain: Dressing Removal	1.3 score on a scale Standard Deviation 1.9	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=20 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Overall performance · Yes	20 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Overall performance · No	0 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Comfort during wear · Yes	19 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Comfort during wear · No	1 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Noise level · Yes	18 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Noise level · No	2 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Discreetness · Yes	20 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Discreetness · No	0 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Portability · Yes	18 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 7: Portability · No	2 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Overall performance · Yes	18 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Overall performance · No	1 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Comfort during wear · Yes	16 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Comfort during wear · No	3 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Noise level · Yes	16 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Noise level · No	3 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Discreetness · Yes	17 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Discreetness · No	2 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Portability · Yes	13 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 14: Portability · No	6 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Overall performance · Yes	13 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Overall performance · No	0 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Comfort during wear · Yes	11 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Comfort during wear · No	2 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Noise level · Yes	10 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Noise level · No	3 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Discreetness · Yes	13 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Discreetness · No	0 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Portability · Yes	12 Participants	—	—
Patient Satisfaction During Wear - Performance: Closed Incisions Only Day 30: Portability · No	1 Participants	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=20 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Showering · Yes	8 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Showering · No	3 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Sleeping · Yes	18 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Sleeping · No	2 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Socializing · Yes	13 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Socializing · No	0 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Working · Yes	2 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 7: Working · No	1 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Showering · Yes	10 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Showering · No	3 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Sleeping · Yes	16 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Sleeping · No	3 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Socializing · Yes	16 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Socializing · No	0 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Working · Yes	2 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 14: Working · No	3 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Showering · Yes	5 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Showering · No	2 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Sleeping · Yes	11 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Sleeping · No	2 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Socializing · Yes	11 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Socializing · No	1 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Working · Yes	4 Participants	—	—
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only Day 30: Working · No	1 Participants	—	—

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=48 dressings 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Ease of Application and Removal: Closed Incisions Only Was it easy to apply the dressing · Yes	48 dressings	—	—
Ease of Application and Removal: Closed Incisions Only Was it easy to apply the dressing · No	0 dressings	—	—
Ease of Application and Removal: Closed Incisions Only Was it easy to remove the dressing · Yes	46 dressings	—	—
Ease of Application and Removal: Closed Incisions Only Was it easy to remove the dressing · No	2 dressings	—	—

SECONDARY outcome

Timeframe: Up to 14 days

Overall dressing wear time in days for Closed Incisions only.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=51 dressings 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Dressing Wear Time: Closed Incisions Only	5.7 days Standard Deviation 2.1	—	—

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=48 dressings 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Dressing Conformability: Closed Incisions Only Yes	48 dressings	—	—
Dressing Conformability: Closed Incisions Only No	0 dressings	—	—

SECONDARY outcome

Timeframe: Up to 14 days

Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=22 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Number of Dressings Used: Closed Incisions Only	2.2 dressings per participant Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=51 dressings 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Reason for Dressing Change: Closed Incisions Only Surgical procedure · No	51 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Routine dressing change · Yes	37 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Routine dressing change · No	14 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Inadequate exudate management · Yes	5 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Inadequate exudate management · No	46 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Pain/discomfort · Yes	0 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Pain/discomfort · No	51 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing damaged · Yes	0 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing damaged · No	51 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing fell off · Yes	0 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing fell off · No	51 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Patient removed dressing · Yes	1 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Patient removed dressing · No	50 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Adverse Event · Yes	4 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Adverse Event · No	47 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Surgical procedure · Yes	0 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Safety alarm · Yes	1 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Safety alarm · No	50 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing components not in place · Yes	1 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Dressing components not in place · No	50 dressings	—	—
Reason for Dressing Change: Closed Incisions Only No vacuum · Yes	2 dressings	—	—
Reason for Dressing Change: Closed Incisions Only No vacuum · No	49 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Other · Yes	3 dressings	—	—
Reason for Dressing Change: Closed Incisions Only Other · No	48 dressings	—	—

SECONDARY outcome

Timeframe: 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)?

Outcome measures

Outcome measures
Measure	PICO 14 Closed Incisions n=19 Participants 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.	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.	PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) 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. 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.
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only Yes	19 Participants	—	—
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only No	0 Participants	—	—

SECONDARY outcome

Timeframe: 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').