A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions (ASOLO-SCI)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wound; Surgical Incision; Surgical Wound Dehiscence; Incision, Surgical; Surgical Wound, Recent
• Intervention / Treatment: Device: Avance® Solo NPWT System

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Welikow, MD; Phone Number: 0046317223045; Email: alexandre.welikow@molnlycke.com
• Study Contact Backup: Name: Tahmina Haider, MSc; Phone Number: 0046739503674; Email: tahmina.haider@molnlycke.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with a low to moderate exuding surgically closed incision; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Collaborators: Syntactx

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Negative Pressure Wound Therapy; Post Market Clinical Follow-up; Vacuum Assisted Closure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Dehiscence
• Other Study ID Numbers: PD-598653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No