Back to resultsStudy to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds (PICO14)
Primary Purpose
Surgical Incision, Ulcer Foot, Ulcer Venous
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PICO 14 single-use Negative Pressure Wound Therapy System
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Incision focused on measuring Closed incision wounds, Chronic wounds, PICO
Eligibility Criteria
Inclusion Criteria:
- The subject must provide written informed consent.
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subject is suitable to participate in the study in the opinion of the Investigator.
Closed Incisions ONLY:
- Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
- Any closed surgical incision in a patient in which the patient is deemed high risk of developing SSI in the opinion of the investigator.
Chronic wounds ONLY:
Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
- *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.
Dehisced surgical wounds ONLY:
Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
- *Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries
Exclusion Criteria:
Contraindications (per the PICO 14 IFU) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
- Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
- Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
- Subjects who have participated previously in this clinical trial
- Subjects with a history of poor compliance with medical treatment.
- Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
- Patients with bleeding disorders, or concomitant use of anticoagulants.
- 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).
Sites / Locations
- Klinikum der Landeshauptstadt Stuttgart gKAöR
- Queen Elizabeth the Queen Mother Hospital
- Northumbria Healthcare NHS Trust
- Nottingham Breast Institute
- Robert Jones and Agnes Hunt Orthopaedic Hospital
- The Lantern Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
PICO 14 Any Wound
PICO 14 Closed Incisions
PICO 14 Chronic/Dehisced Surgical Wounds
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Functional clinical performance of the PICO14 NPWT system over the treatment period comprised.
Composite Clinical Success will be defined as a binary variable (1/0) - 1 if both the following are true, 0 if either one is false:
Nominal pressure is in the interval 80mmHg ±6mmHg. (Delivery of negative pressure will be measured by download of the built-in data chip from the PICO 14 devices.)
No exudate leakage. (Occurrence of exudate leaks will be recorded by the clinician.)
Composite Clinical Success will be reported as a count and percentage with a 95% CI.
Secondary Outcome Measures
Scar quality- 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 of both scales can be simply calculated by summing up the scores of each of the six items. The Total Score will therefore range from 6 to 60. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers.
Incidence of Surgical Site Infection (SSI) within 30 days of surgery- Closed Incisions Only
Assessment of incision infection will be completed as specified per the CDC definitions of nosocomial surgical site infections at each of the specified time points to identify infection.
Incidence of Surgical Site Complication (SSC) within 30 days of surgery: Closed Incisions Only
Incidence of Surgical site Complications (SSC) as applicable: dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess.
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days: Closed Incisions Only
The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21, and 28 days: Chronic and Dehisced Surgical Wounds
The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.
Ease of application and removal: Chronic and Dehisced Surgical Wounds
Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds to be determined by Yes/No responses to the questions "Was it easy to apply the dressing?" and "Was it easy to remove the dressing?".
Ease of application and removal: Closed Incisions Only
Ease of application and removal of the PICO 14 dressing for Closed Incisions only to be determined by Yes/No responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing". The frequency of the responses will be calculated.
Dressing wear time: Chronic and Dehisced Surgical Wounds
Dressing wear time (days) will be summarized as wear time per subject by Chronic and Dehisced Surgical Wounds at 28 days.
Dressing wear time: Closed Incisions Only
Dressing wear time (days) will be summarized as wear time per subject by Closed Incisions only at 14 days.
Dressing conformability: Chronic and Dehisced Surgical Wounds Only
Dressing conforms to the wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"
Dressing conformability: Closed Incisions Only
Dressing conforms to the closed incision wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"
Dressing change frequency: Chronic and Dehisced Surgical Wounds
Dressing change frequency will be summarized as the number of dressings per subject for Chronic and Dehisced Surgical Wounds
Dressing change frequency: Closed Incisions Only
Dressing change frequency will be summarized as the number of dressings per subject for Closed Incisions.
Reason for dressing change: Chronic and Dehisced Surgical Wounds
Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Chronic and Dehisced Surgical Wounds. Frequency of reasons will be summarized.
Reason for dressing change: Closed Incisions Only
Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Closed Incisions only. Frequency of reasons will be summarized.
Proportion of patients who said they were satisfied with the product: Chronic and Dehisced Surgical Wounds
Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)
Proportion of Patients who said they were satisfied with the product: Closed Incisions Only
Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds
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.
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
Level of pain on 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.
Percentage change in area of Wound: Chronic and Dehisced Surgical Wounds
The reference wound area will be captured at each study visit. Percentage change in area will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.
Percentage change in volume of Wound: Chronic and Dehisced Surgical Wounds
The reference wound volume will be captured at each study visit. Percentage change in volume will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.
Incidence of Clinical Infection: Chronic and Dehisced Surgical Wounds
Presence of infection as determined by the clinical signs and symptoms
Appearance of the Wound as determined by a Modified Bates-Jensen Wound Assessment Tool: Chronic and Dehisced Surgical Wounds
Appearance of the wound will be determined using a Modified Bates-Jensen Wound Assessment Tool for those characteristics measured (wound size, depth, edges, undermining, type of necrotic tissue and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) are each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05234632
Brief Title
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
Acronym
PICO14
Official Title
A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to enrolment issues with dehisced and DFU's wounds
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multi-center, open label study evaluating the performance of PICO14 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg, Pressure Ulcer, Wound Dehiscence
Keywords
Closed incision wounds, Chronic wounds, PICO
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PICO 14 Any Wound
Arm Type
Experimental
Arm Description
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.
Arm Title
PICO 14 Closed Incisions
Arm Type
Experimental
Arm Description
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.
Arm Title
PICO 14 Chronic/Dehisced Surgical Wounds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PICO 14 single-use Negative Pressure Wound Therapy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional clinical performance of the PICO14 NPWT system over the treatment period comprised.
Description
Composite Clinical Success will be defined as a binary variable (1/0) - 1 if both the following are true, 0 if either one is false:
Nominal pressure is in the interval 80mmHg ±6mmHg. (Delivery of negative pressure will be measured by download of the built-in data chip from the PICO 14 devices.)
No exudate leakage. (Occurrence of exudate leaks will be recorded by the clinician.)
Composite Clinical Success will be reported as a count and percentage with a 95% CI.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Scar quality- CLOSED INCISION ONLY
Description
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 of both scales can be simply calculated by summing up the scores of each of the six items. The Total Score will therefore range from 6 to 60. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers.
Time Frame
Day 14 and Day 30
Title
Incidence of Surgical Site Infection (SSI) within 30 days of surgery- Closed Incisions Only
Description
Assessment of incision infection will be completed as specified per the CDC definitions of nosocomial surgical site infections at each of the specified time points to identify infection.
Time Frame
Within 30 days of surgery
Title
Incidence of Surgical Site Complication (SSC) within 30 days of surgery: Closed Incisions Only
Description
Incidence of Surgical site Complications (SSC) as applicable: dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess.
Time Frame
Within 30 days of surgery
Title
Condition of peri-wound skin assessed through visual inspection at 7, 14 and 30 days: Closed Incisions Only
Description
The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.
Time Frame
7 days, 14 days, and 30 days
Title
Condition of peri-wound skin assessed through visual inspection at 7, 14, 21, and 28 days: Chronic and Dehisced Surgical Wounds
Description
The clinician will assess whether the skin appears healthy or if any of the following characteristics apply: fragile, inflamed, eczematous, dry/flaky, macerated or has erythema.
Time Frame
7 days, 14 days, 21 days, and 28 days
Title
Ease of application and removal: Chronic and Dehisced Surgical Wounds
Description
Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds to be determined by Yes/No responses to the questions "Was it easy to apply the dressing?" and "Was it easy to remove the dressing?".
Time Frame
28 days
Title
Ease of application and removal: Closed Incisions Only
Description
Ease of application and removal of the PICO 14 dressing for Closed Incisions only to be determined by Yes/No responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing". The frequency of the responses will be calculated.
Time Frame
14 days
Title
Dressing wear time: Chronic and Dehisced Surgical Wounds
Description
Dressing wear time (days) will be summarized as wear time per subject by Chronic and Dehisced Surgical Wounds at 28 days.
Time Frame
28 days
Title
Dressing wear time: Closed Incisions Only
Description
Dressing wear time (days) will be summarized as wear time per subject by Closed Incisions only at 14 days.
Time Frame
14 days
Title
Dressing conformability: Chronic and Dehisced Surgical Wounds Only
Description
Dressing conforms to the wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"
Time Frame
28 days
Title
Dressing conformability: Closed Incisions Only
Description
Dressing conforms to the closed incision wound. This will be assessed by calculating the frequency of response options Yes or No to the question "Was the dressing conformable on the incision/wound?"
Time Frame
14 days
Title
Dressing change frequency: Chronic and Dehisced Surgical Wounds
Description
Dressing change frequency will be summarized as the number of dressings per subject for Chronic and Dehisced Surgical Wounds
Time Frame
28 days
Title
Dressing change frequency: Closed Incisions Only
Description
Dressing change frequency will be summarized as the number of dressings per subject for Closed Incisions.
Time Frame
30 days
Title
Reason for dressing change: Chronic and Dehisced Surgical Wounds
Description
Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Chronic and Dehisced Surgical Wounds. Frequency of reasons will be summarized.
Time Frame
28 days
Title
Reason for dressing change: Closed Incisions Only
Description
Reason for dressing change (e.g. routine, inadequate exudate management, pain/discomfort, damage to dressing, dressing fell off, removed by patient no vacuum,) for Closed Incisions only. Frequency of reasons will be summarized.
Time Frame
30 days
Title
Proportion of patients who said they were satisfied with the product: Chronic and Dehisced Surgical Wounds
Description
Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)
Time Frame
28 days
Title
Proportion of Patients who said they were satisfied with the product: Closed Incisions Only
Description
Patient satisfaction will be measured by asking the question if they are satisfied with the overall performance of the PICO 14 system (response options of Yes or No)
Time Frame
14 days
Title
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds
Description
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.
Time Frame
28 days
Title
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
Description
Level of pain on 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.
Time Frame
14 days
Title
Percentage change in area of Wound: Chronic and Dehisced Surgical Wounds
Description
The reference wound area will be captured at each study visit. Percentage change in area will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.
Time Frame
7, 14, 21, and 28 days
Title
Percentage change in volume of Wound: Chronic and Dehisced Surgical Wounds
Description
The reference wound volume will be captured at each study visit. Percentage change in volume will be calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits.
Time Frame
7, 14, 21, and 28 days
Title
Incidence of Clinical Infection: Chronic and Dehisced Surgical Wounds
Description
Presence of infection as determined by the clinical signs and symptoms
Time Frame
28 days
Title
Appearance of the Wound as determined by a Modified Bates-Jensen Wound Assessment Tool: Chronic and Dehisced Surgical Wounds
Description
Appearance of the wound will be determined using a Modified Bates-Jensen Wound Assessment Tool for those characteristics measured (wound size, depth, edges, undermining, type of necrotic tissue and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) are each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Evaluation of PICO14 in terms of the overall acceptability of the device from the clinician's perspective
Description
Overall acceptability of the device will be determined by the clinician's response to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)? (Yes/No response options).
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must provide written informed consent.
Subjects eighteen (18) years of age or older.
Willing and able to make all required study visits.
Able to follow instructions.
Subject is suitable to participate in the study in the opinion of the Investigator.
Closed Incisions ONLY:
Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
Any closed surgical incision in a patient in which the patient is deemed high risk of developing SSI in the opinion of the investigator.
Chronic wounds ONLY:
Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.
Dehisced surgical wounds ONLY:
Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
*Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries
Exclusion Criteria:
Contraindications (per the PICO 14 IFU) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
Subjects who have participated previously in this clinical trial
Subjects with a history of poor compliance with medical treatment.
Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
Patients with bleeding disorders, or concomitant use of anticoagulants.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Elizabeth Huddleston
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum der Landeshauptstadt Stuttgart gKAöR
City
Stuttgart
ZIP/Postal Code
D-70374
Country
Germany
Facility Name
Queen Elizabeth the Queen Mother Hospital
City
Margate
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Trust
City
Newcastle
Country
United Kingdom
Facility Name
Nottingham Breast Institute
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Robert Jones and Agnes Hunt Orthopaedic Hospital
City
Oswestry
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Facility Name
The Lantern Centre
City
Preston
ZIP/Postal Code
PR2 8DW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
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