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NCT05902793

Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds

Completed NA Results posted Last updated 11 March 2025
What this trial tests

NA trial testing Investigational device: V.A.C. VERAFLO™ Dressing Kit in Wound Healing in 170 participants. Completed in 19 September 2023.

Timeline
4 August 2020
Primary endpoint
18 September 2023
19 September 2023

Quick facts

Lead sponsorKCI USA, Inc
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment170
Start date4 August 2020
Primary completion18 September 2023
Estimated completion19 September 2023
Sites4 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

KCI USA, Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Wound Healing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Wound Volume Reduction Rate (Unit: %) Primary · over 14 days or until deemed ready for closure by investigator (whichever occurred first)

percent of total wound volume change relative to baseline over 14 days or until deemed ready for closure by investigator (whichever occurred first) over 14 days or until deemed ready for closure by investigator (whichever occurred first)

GroupValue95% CI
Investigational Device: V.A.C. VERAFLO™ Dressing Kit62.15± 43.485
Comparator Device: Negative Pressure Wound Drainage Material65.04± 40.088
Time to Completion of Wound Bed Preparation (Unit: Day) Secondary · Over 14 days or until deemed ready for closure by investigator (whichever occurred first)

duration in days from the randomization until target wound ready for closure by secondary intervention judged by investigator.

GroupValue95% CI
Investigational Device: V.A.C. VERAFLO™ Dressing Kit9.09.0 – 10.0
Comparator Device: Negative Pressure Wound Drainage Material9.09.0 – 10.0
Wound Area Reduction Rate (Unit: %) Secondary · Over 14 days or until deemed ready for closure by investigator (whichever occurred first)

percent of total wound area change over 14 days or until deemed ready for closure by investigator (whichever occurred first)

GroupValue95% CI
Investigational Device: V.A.C. VERAFLO™ Dressing Kit19.21± 23.267
Comparator Device: Negative Pressure Wound Drainage Material27.20± 21.439

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 14 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Investigational Device: V.A.C. VERAFLO™ Dressing Kit
Serious: 0/84 (0%)
Deaths: 0/84
Comparator Device: Negative Pressure Wound Drainage Material
Serious: 1/85 (1%)
Deaths: 0/85

Serious adverse events (1 terms)

ReactionSystemInvestigational Device: V.…Comparator Device: Negativ…
Intestinal obstructionGastrointestinal disorders
Other adverse events (38 terms — click to expand)

ReactionSystemInvestigational Device: V.…Comparator Device: Negativ…
ConstipationGastrointestinal disorders
Medical device site painGeneral disorders
PainGeneral disorders
Procedural painInjury, poisoning and procedural complications
PyrexiaGeneral disorders
InflammationGeneral disorders
DiarrhoeaGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
BlisterSkin and subcutaneous tissue disorders
Dermatitis contactSkin and subcutaneous tissue disorders
Blood pressure increasedInvestigations
Pain in extremityMusculoskeletal and connective tissue disorders
HyperpyrexiaGeneral disorders
Medical device site exfoliationGeneral disorders
Epigastric discomfortGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Joint injuryInjury, poisoning and procedural complications
Skin injuryInjury, poisoning and procedural complications
Wound complicationInjury, poisoning and procedural complications
Wound haemorrhageInjury, poisoning and procedural complications
PruritusSkin and subcutaneous tissue disorders
Blood glucose decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
Neck painMusculoskeletal and connective tissue disorders
Drug hypersensitivityImmune system disorders
HypersensitivityImmune system disorders
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Wound infectionInfections and infestations
InsomniaPsychiatric disorders
Sleep disorderPsychiatric disorders
AnaemiaBlood and lymphatic system disorders
HypercoagulationBlood and lymphatic system disorders
Decreased appetiteMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders

Most-reported serious reactions: Intestinal obstruction.

Data from ClinicalTrials.gov NCT05902793 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Wound Healing

Currently open trials in the same condition.

Other KCI USA, Inc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05902793.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing