Surgical IncisionPICO14NCT05234632
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
An observational study of Surgical Incision and Ulcer Foot, run by Smith & Nephew, Inc. at 6 sites in 2 countries.
Trial summary
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision, Ulcer Foot, Ulcer Venous
- What is being tested?
- PICO 14 single-use Negative Pressure Wound Therapy System
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 22 Sep 2020to 23 Sep 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical wounds and post-operative incisions. The patients will be recruited from up to 7 sites in the United Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.
Who may be able to join
- The subject must provide written informed consent.
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subject is suitable to participate in the study in the opinion of the Investigator.
- Closed Incisions ONLY:
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- Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
- Any closed surgical incision in a patient in which the patient is deemed high risk of developing surgical site infection (SSI) in the opinion of the investigator.
- Chronic wounds ONLY:
- Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
- *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.
- Dehisced surgical wounds ONLY:
- Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
- *Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries
Who cannot join
- Contraindications (per the PICO 14 Instructions for use [IFU]) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
- Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
- Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
- Subjects who have participated previously in this clinical trial
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- Subjects with a history of poor compliance with medical treatment.
- Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
- Pregnancy.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Presence of infection as determined by the clinical signs and symptoms (International wound infection).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom5 sites
Queen Elizabeth the Queen Mother Hospital
Margate
Northumbria Healthcare NHS Trust
Newcastle
Nottingham Breast Institute
Nottingham, NG5 1PB
Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, SY10 7AG
The Lantern Centre
Preston, PR2 8DW
Germany1 site
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, D-70374
About this study
Official title: A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.
The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg, Pressure Ulcer, Wound Dehiscence
- Being tested
- PICO 14 single-use Negative Pressure Wound Therapy System
- Keywords
- Closed incision wounds, Chronic wounds, PICO
- Medical subject headings
- Surgical Wound, Foot Ulcer, Varicose Ulcer, Leg Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO 14 single-use Negative Pressure Wound Therapy SystemDevice
The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PICO 14 single-use Negative Pressure Wound Therapy System | |
| 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. Receives: Device: PICO 14 single-use Negative Pressure Wound Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Exudate Management: Occurrence of No Exudate Leaks
Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.
Measured: Up to 30 Days
Secondary outcomes (35)
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.
Measured: Day 14 and Day 30
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only
Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No).
Measured: Day 7, Day 14, and Day 30
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only
Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No).
Measured: Day 7, Day 14, and Day 30
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only
The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply:
- Healthy
- Fragile
- Inflamed
- Erythematous
- Oedematous
- Eczematous
- Macerated
- Bruising
- Dry and flaky
- Other
Measured: Day 7, Day 14, and Day 30
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
Measured: Up to 14 Days
Patient Satisfaction During Wear - Performance: Closed Incisions Only
Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:
- Overall performance
- Comfort during wear
- Noise level
- Discreetness
- Portability
Measured: Day 7, Day 14, and Day 30
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only
Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following:
- Showering
- Sleeping
- Socializing
- Working
Measured: Day 7, Day 14, and Day 30
Ease of Application and Removal: Closed Incisions Only
Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
Measured: Up to 14 days
Dressing Wear Time: Closed Incisions Only
Overall dressing wear time in days for Closed Incisions only.
Measured: Up to 14 days
Dressing Conformability: Closed Incisions Only
Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
Measured: Up to 14 days
Number of Dressings Used: Closed Incisions Only
Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.
Measured: Up to 14 days
Reason for Dressing Change: Closed Incisions Only
Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No':
- Routine dressing change
- Inadequate exudate management
- Pain/discomfort
- Dressing damaged
- Dressing fell off
- Patient removed dressing
- Adverse Event
- Surgical procedure
- Safety alarm
- Dressing components not in place
- No vacuum
- other
Measured: Up to 14 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
Measured: Day 14
Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only
Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No').
Measured: Day 0, Day 7, Day 14, Day 21, and Day 28
Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
Measured: Screening and Day 28
Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
Measured: Screening and Day 28
Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
Measured: Screening and Day 28
Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:
- <25% of wound bed covered
- 25% to 50% of wound covered
- 50% to < 75% of wound covered
- 75% to 100% of wound covered
Measured: Screening and Day 28
Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:
- White/grey non-viable tissue
- Non-adherent, yellow slough
- Loosely adherent, yellow slough
- Adherent, soft, black eschar
- Firmly adherent, hard/black eschar
Measured: Screening and Day 28
Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:
- Skin intact or partial thickness wound
- Bright, beefy red; 75% to 100% of wound filled \&/or tissue overgrowth
- Bright, beefy red; < 75% \& >25% of wound filled
- Pink, \&/or dull, dusky red \&/or fills <25% of wound
- No granulation tissue present
Measured: Screening and Day 28
Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with:
- 100% wound covered, surface intact
- 75% to < 100% wound covered \&/or epithelial tissue extends to > 0.5 cm into wound bed
- 50% to < 75% wound covered \&/or epithelial tissue extends to < 0.5 cm into wound bed
- 25% to < 50% wound covered
- < 25% wound covered
Measured: Screening and Day 28
Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
Measured: Screening and Day 28
Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as:
- Light
- Moderate
- Heavy
Measured: Screening and Day 28
Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only
The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply:
- Normal
- Erythematous
- Oedematous
- Eczematous
- Excoriated
- Macerated
- Indurated
- Other
Measured: Day 0, Day 7, Day 14, Day 21, and Day 28
Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only
The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
Measured: Day 7, Day 14, Day 21, and Day 28
Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only
The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
Measured: Day 7, Day 14, Day 21, and Day 28
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only
Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
Measured: Up to 28 days
Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only
Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:
- Overall performance
- Comfort during wear
- Noise level
- Discreetness
- Portability
Measured: Day 14 and Day 28
Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only
Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following:
- Showering
- Sleeping
- Socializing
- Working
Measured: Day 14 and Day 28
Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only
Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
Measured: Up to 28 days
Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only
Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.
Measured: Up to 28 days
Dressing Conformability: Chronic and Dehisced Surgical Wounds Only
Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
Measured: Up to 28 days
Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only
Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds
Measured: Up to 28 days
Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only
Reason for dressing change for Chronic and Dehisced Surgical Wounds only. Count of occurrences by dressing were categorized as 'Yes' or 'No':
- Routine dressing change
- Inadequate exudate management
- Pain/discomfort
- Dressing damaged
- Dressing fell off
- Patient removed dressing
- Adverse Event
- Surgical procedure
- Safety alarm
- Dressing components not in place
- No vacuum
- other
Measured: Up to 28 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start22 Sep 2020
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Why it stopped: Due to enrolment issues with dehisced and DFU's wounds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Jahnke, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234632
- Sponsor's protocol ID
- PICO14.WND.PRO.2019.03
- Acronym
- PICO14
- Status last verified
- Dec 2023
- First submitted
- 28 May 2021
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT05234632
- Acronym / sponsor ID
- PICO14 / PICO14.WND.PRO.2019.03
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg, Pressure Ulcer, Wound Dehiscence
- Keywords
- Closed incision wounds, Chronic wounds, PICO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to enrolment issues with dehisced and DFU's wounds
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.
The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO 14 Closed Incisions | – | Device: PICO 14 single-use Negative Pressure Wound Therapy SystemAny 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 Chronic/Dehisced Surgical Wounds | – | Device: PICO 14 single-use Negative Pressure Wound Therapy SystemAny 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical wounds and post-operative incisions. The patients will be recruited from up to 7 sites in the United Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.
Key inclusion criteria (14 listed)
- The subject must provide written informed consent.
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subject is suitable to participate in the study in the opinion of the Investigator.
Key exclusion criteria (11 listed)
- Contraindications (per the PICO 14 Instructions for use [IFU]) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
- Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
- Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO 14 single-use Negative Pressure Wound Therapy SystemThe 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. | Device | PICO 14 Chronic/Dehisced Surgical Wounds, PICO 14 Closed Incisions |
Primary outcome
Delivery of Nominal -80mmHg Negative Pressure
Time frame: Day 30
Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.
Exudate Management: Occurrence of No Exudate Leaks
Time frame: Up to 30 Days
Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.
35 secondary outcomes
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only
Time frame: Day 14 and Day 30
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only
Time frame: Day 7, Day 14, and Day 30
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only
Time frame: Day 7, Day 14, and Day 30
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only
Time frame: Day 7, Day 14, and Day 30
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
Time frame: Up to 14 Days
Patient Satisfaction During Wear - Performance: Closed Incisions Only
Time frame: Day 7, Day 14, and Day 30
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only
Time frame: Day 7, Day 14, and Day 30
Ease of Application and Removal: Closed Incisions Only
Time frame: Up to 14 days
Dressing Wear Time: Closed Incisions Only
Time frame: Up to 14 days
Dressing Conformability: Closed Incisions Only
Time frame: Up to 14 days
Number of Dressings Used: Closed Incisions Only
Time frame: Up to 14 days
Reason for Dressing Change: Closed Incisions Only
Time frame: Up to 14 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only
Time frame: Day 14
Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 0, Day 7, Day 14, Day 21, and Day 28
Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only
Time frame: Screening and Day 28
Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 0, Day 7, Day 14, Day 21, and Day 28
Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 7, Day 14, Day 21, and Day 28
Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 7, Day 14, Day 21, and Day 28
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 14 and Day 28
Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 14 and Day 28
Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Dressing Conformability: Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only
Time frame: Up to 28 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Jahnke study director
Smith & Nephew, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Incision and Ulcer Foot, run by Smith & Nephew, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of Nominal -80mmHg Negative Pressure (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.