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

Wound Healing Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902793
• Other study ID #: EM-05-015052
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: October 21, 2023

Study information

• Verified date: June 2023
• Source: 3M
• Contact: Yajuan Gong, PM
• Phone: +86 021-22105373
• Email: ygong3[@]mmm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: October 21, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Only adult subjects meeting all of the following criteria to be considered for participation:

1. Subject voluntarily participate in the trial and sign the informed consent form, and is willing to comply with protocol and all visits

2. Is anticipated to be an inpatient for a minimum of 6 days

3. Age: between 18 years and 70 years

4. Patient with open wounds from various etiologies with extensive soft tissue damage after definitive surgical debridement and appropriate for NPWT

5. 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.

6. Female subjects of reproductive potential must have a negative pregnancy test result and must not be lactating at the screening visit.

7. 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:

1. Subject undergoing chemotherapy

2. Subject with known immunodeficiency

3. Subject with serious complications or serious systemic infection

4. Known bleeding disorder or has received or is planning to receive long-term anticoagulation therapy

5. Known allergic reactions/hypersensitivity to any of the study treatment dressings components

6. Target wound is a burn wound

7. A wound open for 6 months or more

8. The subject's targeted traumatic wound injury is a craniofacial wound

9. There is implant (such as cardiac pacemaker, bone nail, bone lamella, artificial joint, artificial bone) visible in the targeted wound.

10. If undermining or tunneling represents approximately 15% or more of the wound.

11. A wound with enteric fistulas.

12. Subject's targeted wound that is contraindicated with investigational device including:

1. Malignancy in the wound

2. Untreated osteomyelitis

3. Non-enteric or unexplored fistulas

4. 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)

5. Unprotected, exposed blood vessel, anastomotic sites, organs, or nerves in direct contact with foam

6. Thoracic or abdominal cavities

7. Unexplored wounds that may communicate with adjacent body cavities

13. Subject's targeted wound that is contraindicated with the control group device and not suitable for participating in the trial judged by investigator

14. Participation in another device or drug study within the past 30 days before screening or during study participation

15. Other subjects who are not suitable for participating in the trial judged by investigator.

16. 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.

17. 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).

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

Device:
• Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit
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.
• Active Comparator: Dressing Name: Negative pressure wound drainage material
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.

Locations

Country	Name	City	State
China	Foshan Hospital of TCM	Foshan	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Xi'an Honghui Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Events (AE) (unit: %)	an AE is any untoward medical occurrence in the course of a trial, whether or not related to the investigational device	Through study completion, up to 14 days
Other	Incidence of Serious Adverse Events (unit: %)	an SAE is any untoward medical occurrence in the course of a trial, whether or not related	Through study completion, up to 14 days
Other	Incidence of Device Deficiencies (unit: %)	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.	Through study completion, up to 14 days
Primary	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)	over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Secondary	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.	Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Secondary	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)	Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Secondary	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	Over 14 days or until deemed ready for closure by investigator (whichever occurred first)