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

Molnlycke Health Care

Status: Unknown

Conditions: Surgical Wound; Surgical Wound, Recent; Surgical Incision; Surgical Wound Dehiscence; Incision, Surgical

Treatments: Device: Avance® Solo NPWT System

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04894604

PD-598653

Details and patient eligibility

About

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).

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Subjects with a low to moderate exuding surgically closed incision

Experimental group

Description:

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.

Treatment:

Device: Avance® Solo NPWT System