A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions

NCT04894604 | Unknown

• 1 other identifier: PD-598653
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Wound progress to baseline

  Day 14 (+0/-2 days)

• Change in wound progress across visits

  Day 7 (+0/-2 days), Day 14 (+0/-2 days)

• Change in lack of dermal opposition

  Day 7 (+0/-2 days), Day 14 (+0/-2 days)

• Change in exudate amount

  Day 7 (+0/-2 days), Day 14 (+0/-2 days)

• Change in exudate nature

  Day 7 (+0/-2 days), Day 14 (+0/-2 days)

Study Arms (1)

Subjects with a low to moderate exuding surgically closed incision

EXPERIMENTAL

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

Interventions

Avance® Solo NPWT System DEVICE

Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.

Subjects with a low to moderate exuding surgically closed incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Signed written Informed Consent Form.
• 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.
• Study subjects that are deemed capable and willing to comply with the protocol instructions.

You may not qualify if:

• Known malignancy in the wound or margins of the wound.
• Untreated and previously confirmed osteomyelitis.
• Non-enteric and unexplored fistulas.
• Necrotic tissue with eschar present.
• Exposed nerves, arteries, veins or organs.
• Exposed anastomotic site.
• Known allergy/hypersensitivity to the dressing or its components.
• Known pregnancy or planning to become pregnant or breastfeeding at time of study participation.
• Participation in another investigative drug or device trial currently or within the last 30 days.
• Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead
• Syntactx: collaborator

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre Welikow, MD

CONTACT

0046317223045; alexandre.welikow@molnlycke.com

Tahmina Haider, MSc

CONTACT

0046739503674; tahmina.haider@molnlycke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group of Subjects (with a low to moderate exuding surgically closed incision) in use of the Avance® Solo NPWT System.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 20, 2021
• Study Start: June 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2022
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share