Performance, Safety and Efficacy of PICO Device.

Wound Heal Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698968
• Other study ID #: CT1703PC7
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: September 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.

Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.

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.

The PICO system has recently been updated with minor modifications that make the system silent during wear. S & N also wish to collect PMCF data in the indications of knee and abdominal incisions in order to make retrospective comparisons with data previously collected for these indications.

The aim of this study is therefore to assess whether the PICO 7 system is a safe and effective therapy for surgically closed incisions, skin grafts and flaps. Effectiveness will be defined by the ability of the system to deliver negative pressure and handle exudate and by percentage of successful skin graft or flap survival at Day 14.

A summary of known and potential risks and benefits to humans of each test article can be found in the Instructions for Use of PICO 7.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Wound Heal

Intervention

Device:
• Negative Pressure Wound Therapy
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.

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano; Sede Ospedale Italiano	Lugano
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Mid Essex Hospital Services	Chelmsford	Essex
United Kingdom	Queen Victoria Hospital	East Grinstead
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
United Kingdom	The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation	Oswestry	Shropshire
United Kingdom	Peterborough City Hospital, North West Anglia NHS Foundation Trust	Peterborough
United Kingdom	Mid-Yorkshire NHS Trust	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria]	For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data	30 Days
Secondary	Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess	For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data	30 Days
Secondary	Percentage of successful skin graft take or flap survival at Days 7, 14 and 30	Assessed by clinician visual assessment	30 Days
Secondary	Visual inspection of peri-wound skin condition	Visual inspection assessment (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) at 7, 14 and 30 days	30 Days
Secondary	Visual Analog Scale (VAS) - pain	Level of subject pain during wear of the PICO 7 system, at dressing removal and at application assessed by VAS scale (pain intensity as none, mild, moderate, or severe) following 7 day therapy	30 Days
Secondary	Dressing wear time in days	Assessed through a combination of data from device microchip and CRF recorded data of any unplanned dressing change	30 Days