Status:
TERMINATED
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Surgical Incision
Ulcer Foot
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ...
Eligibility Criteria
Inclusion
- The subject must provide written informed consent.
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subject is suitable to participate in the study in the opinion of the Investigator.
- Closed Incisions ONLY:
- Subject has a suitable, closed surgical incision which the clinician considers is suitable for PICO therapy, where it is expected that the therapy will be applied for up to 14 days.
- Any closed surgical incision in a patient in which the patient is deemed high risk of developing surgical site infection (SSI) in the opinion of the investigator.
- Chronic wounds ONLY:
- Patients with any chronic wound\* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
- \*Chronic wound in this study is defined as any wound of less than three months duration that is not healing after 4 weeks of standard care and having addressed the underlying cause.
- Dehisced surgical wounds ONLY:
- Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
- \*Wound dehiscence is a surgical complication in which two sides of a surgical incision separate and rupture along the incision, dehiscence typically is diagnosed after 2-3 days postsurgery and up to a month with more complicated surgeries
Exclusion
- Contraindications (per the PICO 14 Instructions for use \[IFU\]) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films \[direct contact with incision\], acrylic adhesives \[direct contact with skin\], polyethylene fabrics and super-absorbent powders \[polyacrylates\]) within the dressing).
- Subjects who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
- Subjects with skin features (e.g. tattoos, skin colour, preexisting scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
- Subjects who have participated previously in this clinical trial
- Subjects with a history of poor compliance with medical treatment.
- Malignant wounds, open abdomen, wounds which have been previously managed with NPWT in the previous four weeks.
- Pregnancy.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Presence of infection as determined by the clinical signs and symptoms (International wound infection).
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05234632
Start Date
September 22 2020
End Date
September 23 2022
Last Update
June 6 2025
Active Locations (6)
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1
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany, D-70374
2
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
3
Northumbria Healthcare NHS Trust
Newcastle, United Kingdom
4
Nottingham Breast Institute
Nottingham, United Kingdom, NG5 1PB