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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04894604
Other study ID # PD-598653
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 30, 2021
Est. completion date March 31, 2022

Study information

Verified date May 2021
Source Molnlycke Health Care AB
Contact Alexandre Welikow, MD
Phone 0046317223045
Email alexandre.welikow@molnlycke.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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 information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date March 31, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: 1. Male or female = 18 years of age. 2. Signed written Informed Consent Form. 3. 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. 4. Study subjects that are deemed capable and willing to comply with the protocol instructions. Exclusion criteria: 1. Known malignancy in the wound or margins of the wound. 2. Untreated and previously confirmed osteomyelitis. 3. Non-enteric and unexplored fistulas. 4. Necrotic tissue with eschar present. 5. Exposed nerves, arteries, veins or organs. 6. Exposed anastomotic site. 7. Known allergy/hypersensitivity to the dressing or its components. 8. Known pregnancy or planning to become pregnant or breastfeeding at time of study participation. 9. Participation in another investigative drug or device trial currently or within the last 30 days. 10. Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Molnlycke Health Care AB Syntactx

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary Wound progress to baseline Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved). Day 14 (+0/-2 days)
Secondary Change in wound progress across visits Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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. Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary Change in exudate amount Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary Change in exudate odour Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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. Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary System wear time Evaluate system wear time in days from baseline to all follow-up visits including potential extra visits. Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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. Day 14 (+0/-2 days)
Secondary 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). Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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. Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary 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). Day 14 (+0/-2 days)
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