Wound HealingNCT05902793
Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds
A study testing Investigational device: V.A.C. VERAFLO™ Dressing Kit and Comparator device: Negative pressure wound drainage material in people with Wound Healing, run by KCI USA, Inc at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Investigational device: V.A.C. VERAFLO™ Dressing Kit and Comparator device: Negative pressure wound drainage material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 4 sitesChina
- Study dates
- 4 Aug 2020to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only adult subjects meeting all of the following criteria to be considered for participation:
- Subject voluntarily participate in the trial and sign the informed consent form, and is willing to comply with protocol and all visits
- Is anticipated to be an inpatient for a minimum of 6 days
- Age: between 18 years and 70 years
- Patient with open wounds from various etiologies with extensive soft tissue damage after definitive surgical debridement and appropriate for NPWT
- The minimum size of the wound as measured by 3D wound imaging prior to entry into the study is 8cm (in any dimension), minimum 1cm in width and 0.8cm in depth. i.e. the minimum wound size is 8cm×1cm×0.8cm. Only one wound per subject will be included in the study, regardless of how many wounds the subject has.
- Female subjects of reproductive potential must have a negative pregnancy test result and must not be lactating at the screening visit.
- Subject must be willing and able to use a highly effective contraception method during study participation.
Who cannot join
- Subject who meets any of the following criteria will be excluded from participation in the study:
- Subject undergoing chemotherapy
- Subject with known immunodeficiency
- Subject with serious complications or serious systemic infection
- Known bleeding disorder or has received or is planning to receive long-term anticoagulation therapy
- Known allergic reactions/hypersensitivity to any of the study treatment dressings components
Show all 25Show fewer
- Target wound is a burn wound
- A wound open for 6 months or more
- The subject's targeted traumatic wound injury is a craniofacial wound
- There is implant (such as cardiac pacemaker, bone nail, bone lamella, artificial joint, artificial bone) visible in the targeted wound.
- If undermining or tunneling represents approximately 15% or more of the wound.
- A wound with enteric fistulas.
- Subject's targeted wound that is contraindicated with investigational device including:
- Malignancy in the wound
- Untreated osteomyelitis
- Non-enteric or unexplored fistulas
- Necrotic tissue with eschar remaining in the wound after surgical debridement (once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
- Unprotected, exposed blood vessel, anastomotic sites, organs, or nerves in direct contact with foam
- Thoracic or abdominal cavities
- Unexplored wounds that may communicate with adjacent body cavities
- Subject's targeted wound that is contraindicated with the control group device and not suitable for participating in the trial judged by investigator
- Participation in another device or drug study within the past 30 days before screening or during study participation
- Other subjects who are not suitable for participating in the trial judged by investigator.
- Wounds that require more than 2 images in order to capture the entire wound. NOTE: each image must not exceed 20 cm in any one direction.
- Wound presents on greater than 50% of the circumference of any part of the body (e.g. wound that wraps around >50% of a leg or arm).
Trial locations and contacts
4 sites in 1 country.
China4 sites
Foshan Hospital of TCM
Foshan, Guangdong
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
Xi'an Honghui Hospital
Xi’an, Shanxi
About this study
Official title: 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
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.
Read the detailed description
The management of wounds represents a significant challenge in healthcare. There are many considerations necessary in developing the optimal treatment plan for achieving wound care goals. Current standard wound treatment in the management of wounds may involve clinical assessment, debridement, antibiotic treatment and local application of antiseptics or antimicrobials, and drainage.
The choice of therapeutic modality is one of many important decisions. Over time, wound care has progressed from the use of products such as dry gauze to advanced moist wound therapies and further to active wound healing therapies. One of such advanced wound healing therapies is negative pressure wound therapy (NPWT), which was developed in the 1990s. NPWT is a technology that is currently widely used in wound care and is promoted for use on complex wounds (open wounds). The therapy of NPWT and solution instillation with a dwell time (NPWTi-d) is used to adjunctively treat high-risk wounds that would benefit from vacuum-assisted drainage and controlled repeated delivery of topical wound solutions, such as normal saline and wound cleansers. Evidences suggests that normal saline is effective and readily available.
V.A.C. VERAFLO™ Dressing Kit, which was the investigational device, was a reticulated open-cell foam polyurethane ester dressing that could deliver normal saline instillation solution to the wound site for NPWTi-d therapy. The V.A.C. VERALFO™ Dressing Kit was approved in July 2010 by the U.S Food and Drug Administration (U.S. FDA) and December 2022 by the China National Medical Products Administration (NMPA).
This trial was designed as a pre-marketing trial of the V.A.C. VERAFLO™ Dressing Kit in China for NMPA registration. The device V.A.C. VERALFO™ Dressing Kit did not get NMPA approval when the study was initiated. On December 20th, 2022, it was approved by NMPA (Registration No.: 国械注进 20223140619).
There were no approved NPWTi-d dressings in China market during protocol design, so a negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. was selected as the control group treatment device, which can apply the NPWT therapy with wall suction.
- Conditions
- Wound Healing
- Being tested
- Investigational device: V.A.C. VERAFLO™ Dressing Kit, Comparator device: Negative pressure wound drainage material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device: V.A.C. VERAFLO™ Dressing Kit | Experimental | NPWT consists in applying topical sub-atmospheric pressure to a wound that is covered with V.A.C. VERAFLO™ Dressing, sealed with drape and connected by a tube to a suction pump applying -125mmhg pressure with a drainage collection system. Instillation and dwell of a topical wound solution in the wound bed cycled at set intervals of 10 minutes every 3.5 hours without negative pressure applied. 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). Receives: Device: Investigational device: V.A.C. VERAFLO™ Dressing Kit |
| Negative pressure wound drainage material | Active comparator | A Negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. (with unspecified pressures ranging from -150 to -380mmHg ) was selected as the control group treatment device, which can apply the NPWT therapy with wall suction. This control device is widely used in clinical institutions in China to deliver NPWT. 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). Receives: Device: Comparator device: Negative pressure wound drainage material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Volume Reduction Rate (Unit: %)
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)
Measured: over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Secondary outcomes (2)
Time to Completion of Wound Bed Preparation (Unit: Day)
duration in days from the randomization until target wound ready for closure by secondary intervention judged by investigator.
Measured: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Wound Area Reduction Rate (Unit: %)
percent of total wound area change over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Measured: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start4 Aug 2020
- Primary completion18 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhijun Pan, Director, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902793
- Sponsor's protocol ID
- EM-05-015052
- Status last verified
- Feb 2025
- First submitted
- 1 May 2023
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05902793
- Acronym / sponsor ID
- EM-05-015052
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The management of wounds represents a significant challenge in healthcare. There are many considerations necessary in developing the optimal treatment plan for achieving wound care goals. Current standard wound treatment in the management of wounds may involve clinical assessment, debridement, antibiotic treatment and local application of antiseptics or antimicrobials, and drainage.
The choice of therapeutic modality is one of many important decisions. Over time, wound care has progressed from the use of products such as dry gauze to advanced moist wound therapies and further to active wound healing therapies. One of such advanced wound healing therapies is negative pressure wound therapy (NPWT), which was developed in the 1990s. NPWT is a technology that is currently widely used in wound care and is promoted for use on complex wounds (open wounds). The therapy of NPWT and solution instillation with a dwell time (NPWTi-d) is used to adjunctively treat high-risk wounds that would benefit from vacuum-assisted drainage and controlled repeated delivery of topical wound solutions, such as normal saline and wound cleansers. Evidences suggests that normal saline is effective and readily available.
V.A.C. VERAFLO™ Dressing Kit, which was the investigational device, was a reticulated open-cell foam polyurethane ester dressing that could deliver normal saline instillation solution to the wound site for NPWTi-d therapy. The V.A.C. VERALFO™ Dressing Kit was approved in July 2010 by the U.S Food and Drug Administration (U.S. FDA) and December 2022 by the China National Medical Products Administration (NMPA).
This trial was designed as a pre-marketing trial of the V.A.C. VERAFLO™ Dressing Kit in China for NMPA registration. The device V.A.C. VERALFO™ Dressing Kit did not get NMPA approval when the study was initiated. On December 20th, 2022, it was approved by NMPA (Registration No.: 国械注进 20223140619).
There were no approved NPWTi-d dressings in China market during protocol design, so a negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. was selected as the control group treatment device, which can apply the NPWT therapy with wall suction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device: V.A.C. VERAFLO™ Dressing Kit | Experimental | Device: Investigational device: V.A.C. VERAFLO™ Dressing KitNPWT consists in applying topical sub-atmospheric pressure to a wound that is covered with V.A.C. VERAFLO™ Dressing, sealed with drape and connected by a tube to a suction pump applying -125mmhg pressure with a drainage collection system. Instillation and dwell of a topical wound solution in the wound bed cycled at set intervals of 10 minutes every 3.5 hours without negative pressure applied. 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). |
| Negative pressure wound drainage material | Active comparator | Device: Comparator device: Negative pressure wound drainage materialA Negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. (with unspecified pressures ranging from -150 to -380mmHg ) was selected as the control group treatment device, which can apply the NPWT therapy with wall suction. This control device is widely used in clinical institutions in China to deliver NPWT. 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Only adult subjects meeting all of the following criteria to be considered for participation:
- Subject voluntarily participate in the trial and sign the informed consent form, and is willing to comply with protocol and all visits
- Is anticipated to be an inpatient for a minimum of 6 days
- Age: between 18 years and 70 years
- Patient with open wounds from various etiologies with extensive soft tissue damage after definitive surgical debridement and appropriate for NPWT
Key exclusion criteria (25 listed)
- Subject who meets any of the following criteria will be excluded from participation in the study:
- Subject undergoing chemotherapy
- Subject with known immunodeficiency
- Subject with serious complications or serious systemic infection
- Known bleeding disorder or has received or is planning to receive long-term anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational device: V.A.C. VERAFLO™ Dressing KitUp 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. | Device | Investigational device: V.A.C. VERAFLO™ Dressing Kit |
| Comparator device: Negative pressure wound drainage materialUp 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. | Device | Negative pressure wound drainage material |
Primary outcome
Wound Volume Reduction Rate (Unit: %)
Time frame: 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)
2 secondary outcomes
Time to Completion of Wound Bed Preparation (Unit: Day)
Time frame: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Wound Area Reduction Rate (Unit: %)
Time frame: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhijun Pan, Director principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device: V.A.C. VERAFLO™ Dressing Kit and Comparator device: Negative pressure wound drainage material in people with Wound Healing, run by KCI USA, Inc at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Volume Reduction Rate (Unit: %) (time frame: over 14 days or until deemed ready for closure by investigator (whichever occurred first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.