Clinical trial NCT04894604: A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incision, Surgical
Surgical Incision
Surgical Wound
Surgical Wound, Recent
Surgical Wound Dehiscence
Keywords: Negative Pressure Wound Therapy
Post Market Clinical Follow-up
Vacuum Assisted Closure
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2021-05-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of Subjects (with a low to moderate exuding surgically closed incision) in use of the Avance® Solo NPWT System.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in wound remaining closed
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
Secondary outcomes:
measure: Wound progress to baseline
timeFrame: Day 14 (+0/-2 days)
measure: Change in wound progress across visits
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Change in lack of dermal opposition
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Change in exudate amount
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Change in exudate nature
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Change in exudate odour
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Change in peri-wound conditions
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Pain assessment
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Absorption and transportation of exudate
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Trauma to the wound's surrounding skin
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: System wear time
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Sounding of alarms
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Product consumption
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Subject quality of life assessment
timeFrame: Day 14 (+0/-2 days)
measure: Ease of application and removal of the Avance® Solo NPWT System
timeFrame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Subject compliance
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days)
measure: Global satisfaction
timeFrame: Day 14 (+0/-2 days)
Other outcomes:
Locations:
Study officials:
References: