Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds
Wound Healing
About this trial
This is an interventional treatment trial for Wound Healing
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).
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
Experimental
Active Comparator
Investigational device: V.A.C. VERAFLO™ Dressing Kit
Dressing Name: Negative pressure wound drainage material
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.