Chronic Wound Clinical Trial
Official title:
Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science BlastX Antimicrobial Wound Gel and TorrentX Wound Wash
This is a 12-week, single-site, open-label prospective study in adult with a chronic wound diagnosis. Subjects will be randomized in equal numbers to either the control treatment arm, antimicrobial control treatment arm, or Next Science treatment arm and will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks.
This is a 12-week, single-site, open-label prospective study in adult subjects ages 18 years of age and older with a chronic wound diagnosis. There will be 15 completed subjects with up to 18 enrolled. Subjects will be randomized in equal numbers to control group (Mepilex Foam dressing); antimicrobial control group (Mepilex Ag Foam dressing); or Next Science group (TorrentX irrigation, BlastX application, and Mepilex foam dressing). Subjects will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks. For the Next Science arm, TorrentX will be used during in-office debridement whereas BlastX will be applied once during the in-office visit and then mid-week with dressing change. DNA and plate count analysis will be taken at maximum of 5 time points: baseline/randomization visit, maximum of 3 treatment visits (Visits 3, 5, and 9), and Visit 13/Study exit (if applicable), with cultures taken pre- and post- debridement. Wound measurements will be taken via imaging from Silhouette camera system at every in-clinic visit. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05076578 -
A Prospective Clinical Study Evaluating the Harvesting of Micografts
|
N/A | |
Recruiting |
NCT04887688 -
Exciflex for Chronic Wound Therapy
|
N/A | |
Enrolling by invitation |
NCT06444035 -
Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
|
N/A | |
Completed |
NCT02417805 -
Cutaneous Microcirculation After Remote Ischemic Preconditioning
|
N/A | |
Completed |
NCT02417818 -
Cutaneous Microcirculation After Plasma Therapy
|
N/A | |
Completed |
NCT02417779 -
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
|
N/A | |
Completed |
NCT03662997 -
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
|
N/A | |
Not yet recruiting |
NCT04132635 -
A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer
|
N/A | |
Withdrawn |
NCT01646502 -
Treatment of Chronic Wound Biofilms
|
N/A | |
Recruiting |
NCT05342740 -
Study of Biomarkers in Diabetic Chronic Wounds
|
||
Suspended |
NCT02577120 -
Wound Healing Endpoint and Recurrence
|
Phase 4 | |
Recruiting |
NCT06185465 -
Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm
|
N/A | |
Completed |
NCT04514783 -
Healthy Tissue Preservation During Wound Debridement by Using Debritom+ Micro Water Jet Technology
|
N/A | |
Terminated |
NCT01429519 -
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05974228 -
Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stageļ¼a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT05414916 -
Pain Relief Strategies for Dressing Change in Chronic Wounds
|
||
Recruiting |
NCT04019639 -
Efficacy of Paste Type Acellular Dermal Matrix(CG Paste) in Chronic Wound Healing
|
N/A | |
Completed |
NCT05810649 -
Local Injection for the Treatment of Chronic Wounds and Pain Caused by Chronic Wounds
|
N/A |