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

Study Overview
=================
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.

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

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Device: Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit
* Device: Active Comparator: Dressing Name: Negative pressure wound drainage material


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit<br>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. | Device: Experimental: Investigational device: V.A.C. VERAFLO™ Dressing Kit<br>* 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.<br>|
| Active Comparator: Dressing Name: Negative pressure wound drainage material<br>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. | Device: Active Comparator: Dressing Name: Negative pressure wound drainage material<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |