Confirm the Safety and Performance of Avance Solo NPWT System

Skin Graft Clinical Trial

— ASOLO-SW  

Official title:

A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754048
• Other study ID #: PD-598655
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: December 6, 2022

Study information

• Verified date: February 2023
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.

Description:

This investigation is designed as a prospective, open, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days.

Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days).

The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will be assessed at each follow-up visit and measured by three outcomes:

• Deteriorated

• No change

• Improved

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female = 18 years.

2. Signed written informed consent.

3. Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use

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. Subjects with known allergies/hypersensitivity to product components.

8. Known pregnancy or planning to become pregnant or lactation at the time of study participation.

9. Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.

10. Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.

Related Conditions & MeSH terms

• Acute Wound
• Dehiscence
• Skin Flap
• Skin Graft
• Subacute Wound
• Traumatic Wound
• Wounds and Injuries

Intervention

Device:
• Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.

Locations

Country	Name	City	State
Belgium	Diensthoofd wondkliniek, UZ Gent	Gent
Belgium	AZ Delta	Roeselare
France	CHU Montpellier	Montpellier
France	Hôpital Paris St Joseph	Paris
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck	Lübeck
Italy	"E. Profili" Civil Hospital	Fabriano
Italy	Ospedale San Raffaele S.r.l.	Milano
Italy	A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista	Torino
Italy	Università dell'Insubria, Varese	Varese

Sponsors (2)

Lead Sponsor	Collaborator
Molnlycke Health Care AB	Syntactx

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wound progress	Wound progress compared to last visit and assessed as: Deteriorated; No change; Improved	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Wound progress	Wound progress compared between baseline and final visit and assessed as: Deteriorated; No change; Improved	28 days
Secondary	Wound dimension	Absolute and percentage change in wound area and volume from baseline to all follow-up visits.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Tissue type	Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Exudate	Change in exudate amount, nature, and odor using a category scoring system from baseline to all follow-up visits.; Amount: none, low, moderate, or high; Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic; Odor: No odor, slight, moderate, strong, very strong	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Peri-wound	Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions: Normal; Erythematous; Oedematous; Eczematous; Excoriated; Macerated; Indurated	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Pain assessment	Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Absorb and transport of exudate	Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Tissue in-growth	Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed
Secondary	Trauma	Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing and also Avance Solo fixation strips at all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Graft take	Change in percentage of graft take and wound epithelization from baseline to all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Flap survival	Change in percentage of flap survival from baseline to all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Wear time	Evaluate Avance Solo NPWT 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), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Alarms	Subject evaluation of the Avance Solo NPWT System properties (number of sounding alarms) assessed with a given scale at all follow-up visits; 0; 1-5; 6-10; 11-15; 16-20; More than 20	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Product consumption	Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Quality of life assessment	Subject evaluation of the Avance Solo NPWT system impact of everyday life	28 days
Secondary	Ease of application	Clinician evaluation of ease of application and removal of the Avance Solo NPWT System using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.	Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Compliance	Evaluate the compliance to Avance Solo NPWT System therapy by average number of hours per 24h that the system has not provided treatment since last visit.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary	Global satisfaction	Evaluate the investigator and subject global satisfaction of the Avance Solo NPWT System in regards to: Very dissatisfied; Dissatisfied; Neither satisfied or dissatisfied; Satisfied; Very satisfied	28 days