An interventional study of Avance® Solo NPWT System in Incision, Surgical, Surgical Incision and Surgical Wound, sponsored by Molnlycke Health Care AB. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment
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).
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.
43 studies on the registry are indexed under Surgical Wound Dehiscence; 12 are open to participants now.
This study's planned enrollment of 34 is below the median of 65 across 33 interventional studies indexed under Surgical Wound Dehiscence.
Browse Surgical Wound Dehiscence studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Device: Avance® Solo NPWT System
Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.
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).
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Wound progress to baseline
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)
Change in wound progress across visits
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)
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Day 14 (+0/-2 days)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Molnlycke Health Care AB