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

Primary Purpose

Wound Healing

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit
Active Comparator: Dressing Name: Negative pressure wound drainage material
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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).

Sites / Locations

  • Anhui Provincial HospitalRecruiting
  • Foshan Hospital of TCMRecruiting
  • Xi'an Honghui HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Dressing Name: Negative pressure wound drainage material

Arm Description

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 and drainage collection system. Instillation and dwell of a topical wound solution allows thorough coverage of the wound bed, thereby cleansing the wound. The topical wound solution that is allowed to dwell over the wound bed also has the potential to dilute and solubilize infectious materials, devitalized tissue and slough. Soaking the dressing with solution prior to removal, thus promoting granulation tissue formation.

Nowadays, there is no approved dressing with solution instillation namely the NPWTi-d therapy in China market. So, a NPWT therapy will be selected in the trial. A Negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. is 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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)
Granulation Tissue Clinical Assessment
Assessment of change in granulation tissue at end of treatment relative to baseline using an ordinal scale: 1 = Skin intact or partial thickness wound 2 = Bright, beefy red; 75% to 100% of wound filled and/or tissue overgrowth 3 = Bright, beefy red; < 75% and > 25% of wound filled 4 = Pink, and/or dull, dusky red and/or fills ~ 25% of wound 5 = No granulation tissue present

Full Information

First Posted
May 1, 2023
Last Updated
June 5, 2023
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT05902793
Brief Title
Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
October 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a prospective, multicenter, randomized (1:1), open-label, parallel controlled, non-inferiority trial evaluating the efficacy and safety of V.A.C. VERAFLO™ Dressing Kit versus Negative Pressure Wound Drainage Material (Guangdong Shuangling Pharmaceuticals Co., Ltd.) for wound bed preparation in open wounds with extensive soft tissue damage. This is a pre-marketing trial of V.A.C. VERAFLO™ Dressing Kit in China for National Medical Products Administration (NMPA) registration. It is anticipated that the primary efficacy endpoint (wound volume reduction rate) of investigational group is non-inferior to that of control group. Up to 170 subjects who meet the eligibility criteria will be randomized to the investigational group or control group at the ratio 1:1. Debridement is not permitted during study treatment. Therefore, 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). 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. 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. The following data in both groups will be recorded and collected: wound volume reduction rate, time to completion of wound bed preparation, wound area reduction rate, incidence of AEs / SAEs and device deficiencies. The efficacy and safety of V.A.C. VERAFLO™ Dressing Kit in treating open wounds that have extensive soft tissue damage will be evaluated according above data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational device: V.A.C. VERAFLO™ Dressing Kit
Arm Type
Experimental
Arm Description
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 and drainage collection system. Instillation and dwell of a topical wound solution allows thorough coverage of the wound bed, thereby cleansing the wound. The topical wound solution that is allowed to dwell over the wound bed also has the potential to dilute and solubilize infectious materials, devitalized tissue and slough. Soaking the dressing with solution prior to removal, thus promoting granulation tissue formation.
Arm Title
Dressing Name: Negative pressure wound drainage material
Arm Type
Active Comparator
Arm Description
Nowadays, there is no approved dressing with solution instillation namely the NPWTi-d therapy in China market. So, a NPWT therapy will be selected in the trial. A Negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. is 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.
Intervention Type
Device
Intervention Name(s)
Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit
Intervention Description
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). 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. 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.
Intervention Type
Device
Intervention Name(s)
Active Comparator: Dressing Name: Negative pressure wound drainage material
Intervention Description
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). 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. 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.
Primary Outcome Measure Information:
Title
Wound Volume Reduction Rate (unit: %)
Description
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)
Time Frame
over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Secondary Outcome Measure Information:
Title
Time to Completion of Wound Bed Preparation (unit: day)
Description
duration in days from the randomization until target wound ready for closure by secondary intervention judged by investigator.
Time Frame
Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Title
Wound Area Reduction Rate (unit: %)
Description
percent of total wound area change over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Time Frame
Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Title
Granulation Tissue Clinical Assessment
Description
Assessment of change in granulation tissue at end of treatment relative to baseline using an ordinal scale: 1 = Skin intact or partial thickness wound 2 = Bright, beefy red; 75% to 100% of wound filled and/or tissue overgrowth 3 = Bright, beefy red; < 75% and > 25% of wound filled 4 = Pink, and/or dull, dusky red and/or fills ~ 25% of wound 5 = No granulation tissue present
Time Frame
Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Other Pre-specified Outcome Measures:
Title
Incidence of Adverse Events (AE) (unit: %)
Description
an AE is any untoward medical occurrence in the course of a trial, whether or not related to the investigational device
Time Frame
Through study completion, up to 14 days
Title
Incidence of Serious Adverse Events (unit: %)
Description
an SAE is any untoward medical occurrence in the course of a trial, whether or not related
Time Frame
Through study completion, up to 14 days
Title
Incidence of Device Deficiencies (unit: %)
Description
Device deficiency refer to any irrational risk in trial, such as tag errors, quality issues, failure, which may threaten subjects' health and safety while investigational device is under normal use.
Time Frame
Through study completion, up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yajuan Gong, PM
Phone
+86 021-22105373
Email
ygong3@mmm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joy Yin, T-manager
Phone
+86 021-22105204
Email
jyin2@mmm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhijun Pan, Director
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xifu Shang
Facility Name
Foshan Hospital of TCM
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqing Gao
Facility Name
Xi'an Honghui Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Song
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhijun Pan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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