Incision, SurgicalASOLO-SCINCT04894604
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
A study testing Avance® Solo NPWT System in people with Incision, Surgical and Surgical Incision, run by Molnlycke Health Care AB.
Trial summary
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incision, Surgical, Surgical Incision, Surgical Wound
- 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
- 34 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 31 Mar 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 of age.
- Signed written Informed Consent Form.
- Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
- Study subjects that are deemed capable and willing to comply with the protocol instructions.
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.
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- Known allergy/hypersensitivity to the dressing or its components.
- Known pregnancy or planning to become pregnant or breastfeeding at time of study participation.
- Participation in another investigative drug or device trial currently or within the last 30 days.
- Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Open, Non-comparative, Post-Market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).
Read the detailed description
The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34).
The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres.
The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment.
As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14.
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent, Surgical Wound Dehiscence
- Being tested
- Avance® Solo NPWT System
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up, Vacuum Assisted Closure
- Medical subject headings
- Surgical Wound, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance® Solo NPWT SystemDevice
Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with a low to moderate exuding surgically closed incision | Experimental | Up to 34 study Subjects with a low to moderate exuding surgically closed incision deemed adequate by the Principal Investigator and clinical team for NPWT treatment. 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 remaining closed
The evaluation of the wound remaining closed is captured through an assessment by the Principal Investigator/clinical team from baseline to the final visit (wound remaining closed yes/no).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary outcomes (17)
Wound progress to baseline
Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
Measured: Day 14 (+0/-2 days)
Change in wound progress across visits
Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in lack of dermal opposition
Lack of dermal opposition as a percentage of the total wound length from baseline to all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate amount
Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate nature
Change in exudate nature from baseline to all follow-up visits (serous/fibrinous/serosanguinous/sanguineous/seropurulent/purulent/foul purulent//haemopurulent/haemorrhagic).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate odour
Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in peri-wound conditions
Change in peri-wound skin condition from baseline to all follow-up visits (normal/erythematous/oedematous/eczematous/excoriated/macerated/indurated).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Pain assessment
Subject evaluation of pain at Avance® Solo Border Dressing and Avance® Solo Fixation Strips removal using a Numeric Rating Scale at each follow-up visit (where the Subject verbally grade their pain on a level from 0 to 10, where 0 indicates no pain and 10 the worst imaginable for the Subject; the NRS will be used before and during dressing removal).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Absorption and transportation of exudate
Clinical assessment of Avance® Solo NPWT System's ability to absorb and/or transport exudate using a rating scale at all follow-up visits (very poor/poor/good/very good).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Trauma to the wound's surrounding skin
Proportion of Subjects with trauma (e.g. blistering) to the wound site and surrounding skin for Avance® Solo Border Dressing and Avance® Solo Fixation Strips at all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
System wear time
Evaluate 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)
Sounding of alarms
Subject evaluation of the system properties (number of sounding alarms) assessed at all follow-up visits (souding of alarms in the following intervals 0, 1-5, 6-10, 11-15, 16-20, more than 20).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Product consumption
Product consumption of the utilised products for the system, from baseline to final visit using the Avance® Solo NPWT System (in total number of Avance® Solo Pumps, Border Dressing, Canisters, Fixation Strips, and batteries).
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Subject quality of life assessment
Subject evaluation of the Avance® Solo NPWT system impact of everyday life at day 14 or final visit. Quality of life is assessed using Numeric Rating Scale (NRS) where the Subject grades how much the treatment has affected their daily life. 0 is equal to no influence, and 10 is equal to considerable influence on everyday life or unbearable. If replying >0, the Subject shall state the presence or absence of the following causes: leakage of dressing, impaired mobility, difficulties in getting dressed, pain, and odour.
Measured: Day 14 (+0/-2 days)
Ease of application and removal of the Avance® Solo NPWT System
Clinician evaluation of ease of application and removal of the Avance® Solo NPWT System using a Numeric Rating Scale collected at baseline and each follow-up visit (from 0 to 10, wherein 0 is equal to no problem with application or removal, and 10 is the worst imaginable situation when applying/removing the system from a Subject).
Measured: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Subject compliance
Evaluate the Subject compliance to Avance® Solo NPWT System therapy at all follow-up visits by the average number of hours per day that the system has not provided NPWT since the Subject's last visit.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Global satisfaction
Evaluation of the Principal Investigator and Subject's global satisfactions with the system at day 14 or final visit (very dissatisfied/dissatisfied/neither dissatisfied or satisfied/satisfied/very satisfied).
Measured: Day 14 (+0/-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Jun 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incision, SurgicalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of Subjects (with a low to moderate exuding surgically closed incision) in use of the Avance® Solo NPWT System.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894604
- Sponsor's protocol ID
- PD-598653
- Acronym
- ASOLO-SCI
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. 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 the Safety and Performance of Avance® Solo NPWT System in Surgically Closed Incisions
- ClinicalTrials.gov ID
- NCT04894604
- Acronym / sponsor ID
- ASOLO-SCI / PD-598653
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent, Surgical Wound Dehiscence
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up, Vacuum Assisted Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 20 May 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 ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).
Detailed description
The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34).
The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres.
The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment.
As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of Subjects (with a low to moderate exuding surgically closed incision) in use of the Avance® Solo NPWT System.
| Arm | Type | Receives |
|---|---|---|
| Subjects with a low to moderate exuding surgically closed incision | Experimental | Device: Avance® Solo NPWT SystemUp to 34 study Subjects with a low to moderate exuding surgically closed incision deemed adequate by the Principal Investigator and clinical team for NPWT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age.
- Signed written Informed Consent Form.
- Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
- Study subjects that are deemed capable and willing to comply with the protocol instructions.
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 SystemApplication of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days. | Device | Subjects with a low to moderate exuding surgically closed incision |
Primary outcome
Change in wound remaining closed
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
The evaluation of the wound remaining closed is captured through an assessment by the Principal Investigator/clinical team from baseline to the final visit (wound remaining closed yes/no).
17 secondary outcomes
Wound progress to baseline
Time frame: Day 14 (+0/-2 days)
Change in wound progress across visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in lack of dermal opposition
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate amount
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate nature
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in exudate odour
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Change in peri-wound conditions
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Pain assessment
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Absorption and transportation of exudate
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Trauma to the wound's surrounding skin
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
System wear time
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Sounding of alarms
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Product consumption
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Subject quality of life assessment
Time frame: Day 14 (+0/-2 days)
Ease of application and removal of the Avance® Solo NPWT System
Time frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Subject compliance
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Global satisfaction
Time frame: Day 14 (+0/-2 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Avance® Solo NPWT System in people with Incision, Surgical and Surgical Incision, run by Molnlycke Health Care AB.
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 4 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: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Welikow, MD (0046317223045, alexandre.welikow@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound remaining closed (time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2021.