Last reviewed · How we verify
NCT04754048: ASOLO-SW
Confirm the Safety and Performance of Avance Solo NPWT System
NA trial testing Avance Solo NPWT System in Acute Wound in 105 participants. Completed in 6 December 2022.
6 December 2022
Quick facts
| Lead sponsor | Molnlycke Health Care AB |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 15 June 2021 |
| Primary completion | 6 December 2022 |
| Estimated completion | 6 December 2022 |
| Sites | 10 locations across Belgium, France, Germany, Italy |
Drugs / interventions tested
- Avance Solo NPWT System
Conditions studied
- Acute Wound — all drugs for Acute Wound →
- Traumatic Wound — all drugs for Traumatic Wound →
- Skin Graft — all drugs for Skin Graft →
- Skin Flap — all drugs for Skin Flap →
Sponsor
Molnlycke Health Care AB — full company profile →
Who can join
18 and older, any sex, with Acute Wound or Traumatic Wound. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04754048
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Avance Solo NPWT System
Trials testing the same drug.
- NCT04753294 — Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems · NA · completed
Other Molnlycke Health Care AB trials
Trials by the same sponsor.
- NCT06661473 — Interventional Study Exploring the Occurrence of Surgical Site Infections. · NA · completed
- NCT06321978 — Mepilex Border Flex Utilization Pilot Spain · recruiting
- NCT05608317 — A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing · NA · recruiting
- NCT05494450 — An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fi · NA · terminated
- NCT04960553 — A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04754048 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Molnlycke Health Care AB
- Last refreshed: 24 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04754048.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing