A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
- Conditions
- Surgical Wound, RecentSurgical Wound DehiscenceIncision, SurgicalSurgical IncisionSurgical Wound
- Interventions
- Device: Avance® Solo NPWT System
- Registration Number
- NCT04894604
- Lead Sponsor
- Molnlycke Health Care AB
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects with a low to moderate exuding surgically closed incision Avance® Solo NPWT System 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.
- Primary Outcome Measures
Name Time Method Change in wound remaining closed 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).
- Secondary Outcome Measures
Name Time Method Wound progress to baseline Day 14 (+0/-2 days) Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
Change in lack of dermal opposition Day 7 (+0/-2 days), Day 14 (+0/-2 days) Lack of dermal opposition as a percentage of the total wound length from baseline to all follow-up visits.
Pain assessment Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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).
Change in exudate amount Day 7 (+0/-2 days), Day 14 (+0/-2 days) Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
Change in wound progress across visits Day 7 (+0/-2 days), Day 14 (+0/-2 days) Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
Change in exudate odour Day 7 (+0/-2 days), Day 14 (+0/-2 days) Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
System wear time Day 7 (+0/-2 days), Day 14 (+0/-2 days) Evaluate system wear time in days from baseline to all follow-up visits including potential extra visits.
Sounding of alarms Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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).
Subject compliance Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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 Day 14 (+0/-2 days) 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).
Change in exudate nature Day 7 (+0/-2 days), Day 14 (+0/-2 days) Change in exudate nature from baseline to all follow-up visits (serous/fibrinous/serosanguinous/sanguineous/seropurulent/purulent/foul purulent//haemopurulent/haemorrhagic).
Absorption and transportation of exudate Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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).
Product consumption Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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 Day 14 (+0/-2 days) 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.
Change in peri-wound conditions Day 7 (+0/-2 days), Day 14 (+0/-2 days) Change in peri-wound skin condition from baseline to all follow-up visits (normal/erythematous/oedematous/eczematous/excoriated/macerated/indurated).
Trauma to the wound's surrounding skin Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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.
Ease of application and removal of the Avance® Solo NPWT System Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days) 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).