A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions (ASOLO-SCI)
Primary Purpose
Incision, Surgical, Surgical Incision, Surgical Wound
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Avance® Solo NPWT System
Sponsored by
About this trial
This is an interventional treatment trial for Incision, Surgical focused on measuring Negative Pressure Wound Therapy, Post Market Clinical Follow-up, Vacuum Assisted Closure
Eligibility Criteria
Inclusion criteria:
- 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.
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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with a low to moderate exuding surgically closed incision
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Wound progress to baseline
Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
Change in wound progress across visits
Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
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.
Change in exudate amount
Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
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).
Change in exudate odour
Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
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).
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).
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).
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.
System wear time
Evaluate system wear time in days from baseline to all follow-up visits including potential extra visits.
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).
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).
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.
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).
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.
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).
Full Information
NCT ID
NCT04894604
First Posted
May 10, 2021
Last Updated
May 17, 2021
Sponsor
Molnlycke Health Care AB
Collaborators
Syntactx
1. Study Identification
Unique Protocol Identification Number
NCT04894604
Brief Title
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
Acronym
ASOLO-SCI
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects with a low to moderate exuding surgically closed incision
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Avance® Solo NPWT System
Intervention Description
Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.
Primary Outcome Measure Information:
Title
Change in wound remaining closed
Description
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).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary Outcome Measure Information:
Title
Wound progress to baseline
Description
Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
Time Frame
Day 14 (+0/-2 days)
Title
Change in wound progress across visits
Description
Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Change in lack of dermal opposition
Description
Lack of dermal opposition as a percentage of the total wound length from baseline to all follow-up visits.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Change in exudate amount
Description
Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Change in exudate nature
Description
Change in exudate nature from baseline to all follow-up visits (serous/fibrinous/serosanguinous/sanguineous/seropurulent/purulent/foul purulent//haemopurulent/haemorrhagic).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Change in exudate odour
Description
Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Change in peri-wound conditions
Description
Change in peri-wound skin condition from baseline to all follow-up visits (normal/erythematous/oedematous/eczematous/excoriated/macerated/indurated).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Pain assessment
Description
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).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Absorption and transportation of exudate
Description
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).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Trauma to the wound's surrounding skin
Description
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.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
System wear time
Description
Evaluate 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)
Title
Sounding of alarms
Description
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).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Product consumption
Description
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).
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Subject quality of life assessment
Description
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.
Time Frame
Day 14 (+0/-2 days)
Title
Ease of application and removal of the Avance® Solo NPWT System
Description
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).
Time Frame
Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Subject compliance
Description
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.
Time Frame
Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Title
Global satisfaction
Description
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).
Time Frame
Day 14 (+0/-2 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 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.
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Welikow, MD
Phone
0046317223045
Email
alexandre.welikow@molnlycke.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tahmina Haider, MSc
Phone
0046739503674
Email
tahmina.haider@molnlycke.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
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