Clinical Trials Logo
  1. Home
  2. Skin Graft
  3. NCT04754048

Confirm the Safety and Performance of Avance Solo NPWT System — ASOLO-SW  

Skin Graft Clinical Trial

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 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04754048
Study type Interventional
Source Molnlycke Health Care AB
Contact
Status Completed
Phase N/A
Start date June 15, 2021
Completion date December 6, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT02210208 - A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT04532593 - Autologous Adipose Stem Cell Assisted Skin Graft N/A
Completed NCT05907915 - Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery N/A
Active, not recruiting NCT04828304 - PLASOMA Ultimate Safety & Efficacy Study N/A
Active, not recruiting NCT04664738 - PEP on a Skin Graft Donor Site Wound Phase 1
Completed NCT02543034 - Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site N/A
Recruiting NCT02185950 - The Effects of Therapeutic Resources on Structure and Function of Normal and Burned Skin N/A
Completed NCT00856934 - Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing Phase 1
Recruiting NCT02090361 - Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts Phase 3
Terminated NCT03992820 - Transcutaneous Electrical Nerve Stimulation for Local Anaesthesia N/A
Enrolling by invitation NCT02677285 - Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing
Recruiting NCT05600634 - Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation
Withdrawn NCT01349894 - SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)