ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
ConditionVenous Leg Ulcer (VLU)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConvaTec Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
DeviceConvaVAC™ Ag+ Negative Pressure Wound Therapy System
Treatment groups
87 Participants
are divided into 1 treatment groupGroup A: ConvaVAC Ag+Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage area reduction (PAR) in wound size at day 14
Difference between wound area at day 0 and day 14 of treatment
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov