ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds

About this trial

Last updated 3 months ago

Study ID

WC-24-452

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 3 months ago

What is this trial about?

Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds. In this study, the focus is on Venous Leg Ulcers (VLUs). Chronic wounds are wounds that do not heal properly or take a long time to heal. They can cause pain, discomfort, and affect your day-to-day life. These types of wounds are also challenging for healthcare teams to treat and can take up a lot of healthcare resources. Venous Leg Ulcers (VLUs) are the most common type of chronic leg wound and affect about 1 in every 100 people. Usual treatments for VLUs include cleaning the wound, using special dressings, applying pressure (compression therapy), and sometimes using creams or dressings that contain silver to fight infection. This study is being done to see if the wound therapy system can help heal venous leg ulcers more effectively and safely.

What are the participation requirements?

Inclusion Criteria

* A wound which is amenable to NPWT and is a VLU as defined by CEAP Classification of C6 or C6R

* Wounds that are clean or contaminated

* Wounds with at least one sign or symptom of infection

* Wounds that in the opinion of the investigator would benefit from an antimicrobial dressing

* ≥18 years old at the time of consent

Exclusion Criteria

* Known sensitivities or allergies to components of the ConvaVAC™ Ag+ NPWT System

* Ischemic wounds with necrotic tissue or eschar present that require sharp debridement

* Wound is too small or too large based on wound dressing size (> 0.5cm2 and < 100cm2)

* Wound depth >7cm

* Wounds requiring concomitant use of DuoDERM® gel, hydrogels, petroleum-based creams/ ointment-/gels per the opinion of the investigator

* Active chemotherapy, radiation therapy, or immunotherapy for cancer or completed treatment within the last 3 months

* Any active malignancy at site of dressing application

* Exposed bone in target wound

* Exposed blood vessels or nerves in target wound

* Systemic infection and/or systemic inflammatory response syndrome (SIRS), sepsis

* Cellulitis in target wound

* Untreated deep tissue infection including but not limited to osteomyelitis, septic arthritis

* Active Pregnancy

* Subjects that in the opinion of the investigator are not suitable for enrollment

* Vulnerable subjects as determined by ICH Harmonized Guideline, Good Clinical Practice E6(R2)