Surgical Wound Clinical Trial
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
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).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Recruiting |
NCT02685761 -
Skin Incisions and Wound Complication Rates for C-sections in Obese Women
|
N/A | |
| Completed |
NCT01297322 -
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
|
N/A | |
| Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Completed |
NCT03193021 -
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
|
N/A | |
| Not yet recruiting |
NCT06028854 -
Blood Characteristics and Abdominal Emergency Surgery
|
||
| Completed |
NCT05646121 -
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
|
||
| Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Recruiting |
NCT06342479 -
Discharge Training for Patients With Intertrochanteric Fracture
|
N/A | |
| Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
| Recruiting |
NCT04994145 -
A Post-Market Clinical Investigation on Mepilex Border Post-Op
|
||
| Recruiting |
NCT04439552 -
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
|
||
| Completed |
NCT05618912 -
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
|
N/A | |
| Completed |
NCT04596163 -
Transversus Thoracis Muscle Plane Block for Sternotomy Pain in Cardiac Surgery
|
N/A | |
| Completed |
NCT04036344 -
Buddy Relationships in DermatoloGic Excisions for Skin Cancer
|
N/A | |
| Completed |
NCT05791721 -
Effect of Preemptive Etoricoxib and Dexamethasone on Wound Healing and Clinical Parameters After Third Molar Surgery
|
Phase 4 | |
| Recruiting |
NCT06073678 -
Photobiomodulation in Palate Wounds: Somatosensorial Evaluation
|
N/A | |
| Completed |
NCT05252260 -
Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty
|
N/A | |
| Withdrawn |
NCT04053946 -
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
|
N/A | |
| Recruiting |
NCT04740775 -
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
|
N/A |