Acute WoundASOLO-SWNCT04754048
Confirm the Safety and Performance of Avance Solo NPWT System
A study testing Avance Solo NPWT System in people with Acute Wound and Traumatic Wound, run by Molnlycke Health Care AB at 10 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Wound, Traumatic Wound, Skin Graft
- What is being tested?
- Avance Solo NPWT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 15 Jun 2021to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Italy4 sites
"E. Profili" Civil Hospital
Fabriano, 60044
Ospedale San Raffaele S.r.l.
Milan, 20132
A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
Torino, 10126
Università dell'Insubria, Varese
Varese, 21100
Belgium2 sites
Diensthoofd wondkliniek, UZ Gent
Ghent, 9000
AZ Delta
Roeselare, 8800
France2 sites
CHU Montpellier
Montpellier, 34090
Hôpital Paris St Joseph
Paris, 75014
Germany2 sites
Franziskus-Krankenhaus Berlin
Berlin, 10787
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
Lübeck, D- 23538
About this study
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
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.
Read the 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
- Conditions
- Acute Wound, Traumatic Wound, Skin Graft, Skin Flap, Subacute Wound, Dehiscence
- Being tested
- Avance Solo NPWT System
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance Solo NPWT SystemDevice
Wound treatment with Avance Solo NPWT System for up to 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic wounds | Experimental | Treatment with negative pressure wound therapy. Receives: Device: Avance Solo NPWT System |
| Subacute wounds (e.g., dehisced wounds) | Experimental | Treatment with negative pressure wound therapy. Receives: Device: Avance Solo NPWT System |
| Flaps and Grafts | Experimental | Treatment with negative pressure wound therapy. Receives: Device: Avance Solo NPWT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound progress
Wound progress compared to last visit and assessed as:
- Deteriorated
- No change
- Improved
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary outcomes (18)
Wound progress
Wound progress compared between baseline and final visit and assessed as:
- Deteriorated
- No change
- Improved
Measured: 28 days
Wound dimension
Absolute and percentage change in wound area and volume from baseline to all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Pain assessment
Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absorb and transport of exudate
Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
Measured: 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
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
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Graft take
Change in percentage of graft take and wound epithelization from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Flap survival
Change in percentage of flap survival from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time
Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessment
Subject evaluation of the Avance Solo NPWT system impact of everyday life
Measured: 28 days
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.
Measured: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Jun 2021
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Three different patient groups treated with the Avance Solo NPWT System
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Hilde Beele, Prof. Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754048
- Sponsor's protocol ID
- PD-598655
- Acronym
- ASOLO-SW
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amann B, Carnali M, Howaldt MN, Goueffic Y, Loschi D, Danneels M, Gibello L, Verzini F, Piffaretti G, Beele H. A study of a canister-based, single-use negative pressure wound therapy system in low-to-moderately exuding wounds. J Wound Care. 2026 Aug 2;35(8):637-645. doi: 10.12968/jowc.2026.0055. Epub 2026 Aug 10.
PubMed 42574340
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04754048
- Acronym / sponsor ID
- ASOLO-SW / PD-598655
- Conditions
- Acute Wound, Traumatic Wound, Skin Graft, Skin Flap, Subacute Wound, Dehiscence
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three different patient groups treated with the Avance Solo NPWT System
| Arm | Type | Receives |
|---|---|---|
| Traumatic wounds | Experimental | Device: Avance Solo NPWT SystemTreatment with negative pressure wound therapy. |
| Subacute wounds (e.g., dehisced wounds) | Experimental | Device: Avance Solo NPWT SystemTreatment with negative pressure wound therapy. |
| Flaps and Grafts | Experimental | Device: Avance Solo NPWT SystemTreatment with negative pressure wound therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avance Solo NPWT SystemWound treatment with Avance Solo NPWT System for up to 28 days. | Device | Flaps and Grafts, Subacute wounds (e.g., dehisced wounds), Traumatic wounds |
Primary outcome
Change in wound progress
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved
18 secondary outcomes
Wound progress
Time frame: 28 days
Wound dimension
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Peri-wound
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Pain assessment
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absorb and transport of exudate
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth
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
Trauma
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Graft take
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Flap survival
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Alarms
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Product consumption
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessment
Time frame: 28 days
Ease of application
Time frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Compliance
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Global satisfaction
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 42574340Amann B, Carnali M, Howaldt MN, Goueffic Y, Loschi D, Danneels M, Gibello L, Verzini F, Piffaretti G, Beele H. A study of a canister-based, single-use negative pressure wound therapy system in low-to-moderately exuding wounds. J Wound Care. 2026 Aug 2;35(8):637-645. doi: 10.12968/jowc.2026.0055. Epub 2026 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde Beele, Prof. Dr. principal investigator
University Hospital, Ghent
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance Solo NPWT System in people with Acute Wound and Traumatic Wound, run by Molnlycke Health Care AB at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Belgium, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound progress (time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.