CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
Investigational device: V.A.C. VERAFLO™ Dressing Kit +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05902793
NCT05902793N/ACompleted

Prospective, Multi-center, Randomized, Open Label, Parallel Group Controlled, Non-inferiority Trial Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds With Extensive Soft Tissue Damage

KCI USA, Inc·interventional·Posted Jun 15, 2023·Updated Mar 11, 2025

In Brief

A clinical study evaluating Investigational device: V.A.C. VERAFLO™ Dressing Kit and Comparator device: Negative pressure wound drainage material for Wound Healing. Completed, enrolled 170 participants across 4 sites.

Detailed Summary

The objectives are to evaluate the efficacy and safety of the V.A.C. VERAFLO™ Dressing Kit for wound bed preparation in open wounds with extensive soft tissue damage in this trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Healing
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 15, 2023
Enrollment StartAug 4, 2020
Primary CompletionSep 18, 2023
Study CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.0 years ago

Interventions

Investigational device: V.A.C. VERAFLO™ Dressing Kitdevice

Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1. Subjects will only be enrolled following definitive surgical debridement (if serial debridement performed) of the target wound. The target wound for each subject in both groups will be treated for up to 14 days or until deemed ready for closure by the investigator (whichever occurs first). The planned study period consists of the following visits: Screening (Day -3 to 0), Day of randomization (Day0), Dressing change visit(s), End of treatment visit. Following study treatment, the wound may be treated with any standard therapy selected by the physician, and then accepted secondary intervention for wound closure according to the wound bed preparation situation.

Comparator device: Negative pressure wound drainage materialdevice

Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1. Subjects will only be enrolled following definitive surgical debridement (if serial debridement performed) of the target wound. The target wound for each subject in both groups will be treated for up to 14 days or until deemed ready for closure by the investigator (whichever occurs first). The planned study period consists of the following visits: Screening (Day -3 to 0), Day of randomization (Day0), Dressing change visit(s), End of treatment visit. Following study treatment, the wound may be treated with any standard therapy selected by the physician, and then accepted secondary intervention for wound closure according to the wound bed preparation situation.