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

NCT05902793 | Completed Results FDA Device

• 1 other identifier: EM-05-015052
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 4

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to Completion of Wound Bed Preparation (Unit: Day)

  Over 14 days or until deemed ready for closure by investigator (whichever occurred first)

• Wound Area Reduction Rate (Unit: %)

  Over 14 days or until deemed ready for closure by investigator (whichever occurred first)

Study Arms (2)

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).

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).

Device: Comparator device: Negative pressure wound drainage material

Interventions

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

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.

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

Comparator device: Negative pressure wound drainage material DEVICE

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.

Negative pressure wound drainage material

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (4)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Foshan Hospital of TCM

Foshan, Guangdong, China

Location

Xi'an Honghui Hospital

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Results Point of Contact

• Title: Dr. Zhijun Pan
• Organization: The Second Affiliated Hospital of Zhejiang University School of Medicine

zepzj@163.com

0571-87783777

Study Officials

• Zhijun Pan, Director

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: June 15, 2023
• Study Start: August 4, 2020
• Primary Completion: September 18, 2023
• Study Completion: September 19, 2023
• Last Updated: March 11, 2025
• Results First Posted: December 19, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)