Performance, Safety and Efficacy of PICO Device.
A Prospective Follow up Study to Assess Performance, Safety and Efficacy of the PICO 7 NPWT System for Surgically Closed Incision Sites and Skin Grafts.
1 other identifier
interventional
50
2 countries
11
Brief Summary
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2019
CompletedSeptember 18, 2019
September 1, 2019
7 months
May 17, 2018
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure
Negative pressure maintenance at nominal 80 mmHg as assessed as the average of the negative pressure values recorded by the device microchip
7 Days
Functional clinical performance of the PICO 7 NPWT system through wound exudate management
Number of NPWT systems with no occurrence of exudate leaks as assessed through a combination of leakage alert data from device microchip and/or clinical data on any leakage observed during the dressing wearing period resulting or not, in an unplanned dressing change
7 Days
Composite Clinical Success
Composite Clinical Success (CCS) defined as a binary variable (1/0) (1 if both of the following are true and 0 if at least one of the two is false): A. Nominal pressure is in the interval 80mmHg ± 7mmHg B. No leakage
7 Days
Secondary Outcomes (6)
Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria]
30 Days
Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess
30 Days
Percentage of successful skin graft take or flap survival at Days 7, 14 and 30
30 Days
Visual inspection of peri-wound skin condition
30 Days
Visual Analog Scale (VAS) - pain
30 Days
- +1 more secondary outcomes
Study Arms (1)
Single prospective intervention
OTHERInterventions
Single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 1 week.
Eligibility Criteria
You may qualify if:
- 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
- Subject has a suitable, closed abdominal or knee surgery incision skin flap or skin graft (STSG, meshed or non-meshed) (if there is more than one incision then the clinician should choose the one which in their opinion is most suited to PICO therapy), that fits under the absorbent dressing area of the appropriate PICO 7 dressing supplied.
You may not qualify if:
- Contraindications (per the PICO 7 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 with extremely fragile skin 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, pre-existing 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 with incisions or skin grafts that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery).
- Subjects with infected skin grafts or incisions at the time of surgery (except for those with perforated bowel or peritonitis).
- Subjects who have participated previously in this clinical trial
- Subjects with a history of poor compliance with medical treatment.
- Subjects with skin grafts to correct pressure ulcers where compression therapy is needed for healing (based on clinicians expertise).
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Ospedale Regionale di Lugano; Sede Ospedale Italiano
Lugano, Switzerland
Mid Essex Hospital Services
Chelmsford, Essex, CM1 7ET, United Kingdom
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation
Oswestry, Shropshire, SY10 7AG, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Queen Victoria Hospital
East Grinstead, RH19 3DZ, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom
Norfolk & Norwich University Hospital
Norwich, NR47UY, United Kingdom
Peterborough City Hospital, North West Anglia NHS Foundation Trust
Peterborough, United Kingdom
Mid-Yorkshire NHS Trust
Wakefield, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rachael Winter
T.J. Smith & Nephew, LTD
- PRINCIPAL INVESTIGATOR
Sudheer Karlakki
Robert Jones & Agnes Hunt Orthopaedic Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
October 9, 2018
Study Start
November 6, 2018
Primary Completion
June 18, 2019
Study Completion
June 18, 2019
Last Updated
September 18, 2019
Record last verified: 2019-09