| 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. | 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. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-77.2± 7.7
- OG001-74.7± 11.4
- OG002-76.2± 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. | 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. | Posted | | Count of Participants | | Participants | | Up to 30 Days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Day 14 and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | 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). | 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). | Posted | | Count of Participants | | Participants | | Day 7, Day 14, and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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). | 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). | Posted | | Count of Participants | | Participants | | Day 7, Day 14, and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Closed Incisions only. | Posted | | Count of Participants | | Participants | | Day 7, Day 14, and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Closed Incisions only. | Posted | | Mean | Standard Deviation | score on a scale | | Up to 14 Days | Dressings | Dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Closed Incisions only. | Posted | | Count of Participants | | Participants | | Day 7, Day 14, and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Closed Incisions only. | Posted | | Count of Participants | | Participants | | Day 7, Day 14, and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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'. | 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 for Closed Incisions only. | Posted | | Count of Units | | dressings | | Up to 14 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Dressing Wear Time: Closed Incisions Only | Overall dressing wear time in days for Closed Incisions only. | 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 for Closed Incisions only. | Posted | | Mean | Standard Deviation | days | | Up to 14 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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'. | 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 for Closed Incisions only. | Posted | | Count of Units | | dressings | | Up to 14 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Number of Dressings Used: Closed Incisions Only | Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions. | 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 for Closed Incisions only. | Posted | | Mean | Standard Deviation | dressings per participant | | Up to 14 days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Closed Incisions only. | Posted | | Count of Units | | dressings | | Up to 14 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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)? | 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 for Closed Incisions only. | Posted | | Count of Participants | | Participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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'). | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Day 0, Day 7, Day 14, Day 21, and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | centimeters (cm) | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | millimeters (mm) | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds with presence of necrotic tissue only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds with presence of necrotic tissue only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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: | 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 for Chronic and Dehisced Surgical Wounds with exudate present only. | Posted | | Count of Participants | | Participants | | Screening and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Day 0, Day 7, Day 14, Day 21, and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | percent change in wound area | | Day 7, Day 14, Day 21, and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | percent change in wound volume | | Day 7, Day 14, Day 21, and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | score on a scale | | Up to 28 days | dressings | dressings | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Day 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Day 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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'. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Units | | dressings | | Up to 28 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | days | | Up to 28 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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'. | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Units | | dressings | | Up to 28 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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 | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Mean | Standard Deviation | dressings per participant | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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
| 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Units | | dressings | | Up to 28 days | dressings | dressings | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 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)? | 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 for Chronic and Dehisced Surgical Wounds only. | Posted | | Count of Participants | | Participants | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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