Back to resultsConfirm the Safety and Performance of Avance Solo NPWT System (ASOLO-SW)
Primary Purpose
Acute Wound, Traumatic Wound, Skin Graft
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Avance Solo NPWT System
Sponsored by
About this trial
This is an interventional treatment trial for Acute Wound focused on measuring Negative Pressure Wound Therapy, Post Market Clinical Follow-up
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 years.
- Signed written informed consent.
- Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use
Exclusion Criteria:
- Known malignancy in the wound or margins of the wound
- Untreated and previously confirmed osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
- Exposed nerves, arteries, veins or organs
- Exposed anastomotic site
- Subjects with known allergies/hypersensitivity to product components.
- Known pregnancy or planning to become pregnant or lactation at the time of study participation.
- Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
- Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.
Sites / Locations
- Diensthoofd wondkliniek, UZ Gent
- AZ Delta
- CHU Montpellier
- Hôpital Paris St Joseph
- Franziskus-Krankenhaus Berlin
- UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
- "E. Profili" Civil Hospital
- Ospedale San Raffaele S.r.l.
- A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
- Università dell'Insubria, Varese
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Traumatic wounds
Subacute wounds (e.g., dehisced wounds)
Flaps and Grafts
Arm Description
Treatment with negative pressure wound therapy.
Treatment with negative pressure wound therapy.
Treatment with negative pressure wound therapy.
Outcomes
Primary Outcome Measures
Change in wound progress
Wound progress compared to last visit and assessed as:
Deteriorated
No change
Improved
Secondary Outcome Measures
Wound progress
Wound progress compared between baseline and final visit and assessed as:
Deteriorated
No change
Improved
Wound dimension
Absolute and percentage change in wound area and volume from baseline to all follow-up visits.
Tissue type
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
Exudate
Change in exudate amount, nature, and odor using a category scoring system from baseline to all follow-up visits.
Amount: none, low, moderate, or high
Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic
Odor: No odor, slight, moderate, strong, very strong
Peri-wound
Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions:
Normal
Erythematous
Oedematous
Eczematous
Excoriated
Macerated
Indurated
Pain assessment
Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.
Absorb and transport of exudate
Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits
Tissue in-growth
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
Trauma
Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing and also Avance Solo fixation strips at all follow-up visits
Graft take
Change in percentage of graft take and wound epithelization from baseline to all follow-up visits
Flap survival
Change in percentage of flap survival from baseline to all follow-up visits
Wear time
Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits
Alarms
Subject evaluation of the Avance Solo NPWT System properties (number of sounding alarms) assessed with a given scale at all follow-up visits
0
1-5
6-10
11-15
16-20
More than 20
Product consumption
Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System
Quality of life assessment
Subject evaluation of the Avance Solo NPWT system impact of everyday life
Ease of application
Clinician evaluation of ease of application and removal of the Avance Solo NPWT System using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.
Compliance
Evaluate the compliance to Avance Solo NPWT System therapy by average number of hours per 24h that the system has not provided treatment since last visit.
Global satisfaction
Evaluate the investigator and subject global satisfaction of the Avance Solo NPWT System in regards to:
Very dissatisfied
Dissatisfied
Neither satisfied or dissatisfied
Satisfied
Very satisfied
Full Information
NCT ID
NCT04754048
First Posted
February 9, 2021
Last Updated
February 23, 2023
Sponsor
Molnlycke Health Care AB
Collaborators
Syntactx
1. Study Identification
Unique Protocol Identification Number
NCT04754048
Brief Title
Confirm the Safety and Performance of Avance Solo NPWT System
Acronym
ASOLO-SW
Official Title
A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
Collaborators
Syntactx
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
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.
Detailed Description
This investigation is designed as a prospective, open, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days.
Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days).
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will be assessed at each follow-up visit and measured by three outcomes:
Deteriorated
No change
Improved
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wound, Traumatic Wound, Skin Graft, Skin Flap, Subacute Wound, Dehiscence
Keywords
Negative Pressure Wound Therapy, Post Market Clinical Follow-up
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Three different patient groups treated with the Avance Solo NPWT System
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traumatic wounds
Arm Type
Experimental
Arm Description
Treatment with negative pressure wound therapy.
Arm Title
Subacute wounds (e.g., dehisced wounds)
Arm Type
Experimental
Arm Description
Treatment with negative pressure wound therapy.
Arm Title
Flaps and Grafts
Arm Type
Experimental
Arm Description
Treatment with negative pressure wound therapy.
Intervention Type
Device
Intervention Name(s)
Avance Solo NPWT System
Intervention Description
Wound treatment with Avance Solo NPWT System for up to 28 days.
Primary Outcome Measure Information:
Title
Change in wound progress
Description
Wound progress compared to last visit and assessed as:
Deteriorated
No change
Improved
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary Outcome Measure Information:
Title
Wound progress
Description
Wound progress compared between baseline and final visit and assessed as:
Deteriorated
No change
Improved
Time Frame
28 days
Title
Wound dimension
Description
Absolute and percentage change in wound area and volume from baseline to all follow-up visits.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Tissue type
Description
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Exudate
Description
Change in exudate amount, nature, and odor using a category scoring system from baseline to all follow-up visits.
Amount: none, low, moderate, or high
Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic
Odor: No odor, slight, moderate, strong, very strong
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Peri-wound
Description
Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions:
Normal
Erythematous
Oedematous
Eczematous
Excoriated
Macerated
Indurated
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Pain assessment
Description
Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Absorb and transport of exudate
Description
Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Tissue in-growth
Description
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed
Title
Trauma
Description
Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing and also Avance Solo fixation strips at all follow-up visits
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Graft take
Description
Change in percentage of graft take and wound epithelization from baseline to all follow-up visits
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Flap survival
Description
Change in percentage of flap survival from baseline to all follow-up visits
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Wear time
Description
Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Alarms
Description
Subject evaluation of the Avance Solo NPWT System properties (number of sounding alarms) assessed with a given scale at all follow-up visits
0
1-5
6-10
11-15
16-20
More than 20
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Product consumption
Description
Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Quality of life assessment
Description
Subject evaluation of the Avance Solo NPWT system impact of everyday life
Time Frame
28 days
Title
Ease of application
Description
Clinician evaluation of ease of application and removal of the Avance Solo NPWT System using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.
Time Frame
Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Compliance
Description
Evaluate the compliance to Avance Solo NPWT System therapy by average number of hours per 24h that the system has not provided treatment since last visit.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Title
Global satisfaction
Description
Evaluate the investigator and subject global satisfaction of the Avance Solo NPWT System in regards to:
Very dissatisfied
Dissatisfied
Neither satisfied or dissatisfied
Satisfied
Very satisfied
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years.
Signed written informed consent.
Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use
Exclusion Criteria:
Known malignancy in the wound or margins of the wound
Untreated and previously confirmed osteomyelitis
Non-enteric and unexplored fistulas
Necrotic tissue with eschar present
Exposed nerves, arteries, veins or organs
Exposed anastomotic site
Subjects with known allergies/hypersensitivity to product components.
Known pregnancy or planning to become pregnant or lactation at the time of study participation.
Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Beele, Prof. Dr.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diensthoofd wondkliniek, UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Hôpital Paris St Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Franziskus-Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
City
Lübeck
ZIP/Postal Code
D- 23538
Country
Germany
Facility Name
"E. Profili" Civil Hospital
City
Fabriano
ZIP/Postal Code
60044
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Università dell'Insubria, Varese
City
Varese
ZIP/Postal Code
21100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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