Wound Healing
Conditions
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
The management of wounds represents a significant challenge in healthcare. There are many considerations necessary in developing the optimal treatment plan for achieving wound care goals. Current standard wound treatment in the management of wounds may involve clinical assessment, debridement, antibiotic treatment and local application of antiseptics or antimicrobials, and drainage. The choice of therapeutic modality is one of many important decisions. Over time, wound care has progressed from the use of products such as dry gauze to advanced moist wound therapies and further to active wound healing therapies. One of such advanced wound healing therapies is negative pressure wound therapy (NPWT), which was developed in the 1990s. NPWT is a technology that is currently widely used in wound care and is promoted for use on complex wounds (open wounds). The therapy of NPWT and solution instillation with a dwell time (NPWTi-d) is used to adjunctively treat high-risk wounds that would benefit from vacuum-assisted drainage and controlled repeated delivery of topical wound solutions, such as normal saline and wound cleansers. Evidences suggests that normal saline is effective and readily available. V.A.C. VERAFLO™ Dressing Kit, which was the investigational device, was a reticulated open-cell foam polyurethane ester dressing that could deliver normal saline instillation solution to the wound site for NPWTi-d therapy. The V.A.C. VERALFO™ Dressing Kit was approved in July 2010 by the U.S Food and Drug Administration (U.S. FDA) and December 2022 by the China National Medical Products Administration (NMPA). This trial was designed as a pre-marketing trial of the V.A.C. VERAFLO™ Dressing Kit in China for NMPA registration. The device V.A.C. VERALFO™ Dressing Kit did not get NMPA approval when the study was initiated. On December 20th, 2022, it was approved by NMPA (Registration No.: 国械注进 20223140619). There were no approved NPWTi-d dressings in China market during protocol design, so a negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. was selected as the control group treatment device, which can apply the NPWT therapy with wall suction.
Interventions
DEVICEInvestigational 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). 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.
DEVICEComparator device: 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). 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.
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Volume Reduction Rate (Unit: %) | over 14 days or until deemed ready for closure by investigator (whichever occurred first) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Completion of Wound Bed Preparation (Unit: Day) | Over 14 days or until deemed ready for closure by investigator (whichever occurred first) | duration in days from the randomization until target wound ready for closure by secondary intervention judged by investigator. |
| Wound Area Reduction Rate (Unit: %) | Over 14 days or until deemed ready for closure by investigator (whichever occurred first) | percent of total wound area change over 14 days or until deemed ready for closure by investigator (whichever occurred first) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Device: V.A.C. VERAFLO™ Dressing Kit 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). | 83 |
| Comparator Device: Negative Pressure Wound Drainage Material 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). | 86 |
| Total | 169 |
Baseline characteristics
| Characteristic | Comparator Device: Negative Pressure Wound Drainage Material | Investigational Device: V.A.C. VERAFLO™ Dressing Kit | Total |
|---|---|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 13.55 | 49.7 years STANDARD_DEVIATION 10.97 | 48.6 years STANDARD_DEVIATION 12.37 |
| Baseline wound area (cm^2) | 50.16 cm^2 STANDARD_DEVIATION 43.57 | 62.87 cm^2 STANDARD_DEVIATION 50.402 | 56.40 cm^2 STANDARD_DEVIATION 47.34 |
| Baseline wound volume (cm^3) | 12.61 cm^3 STANDARD_DEVIATION 16.264 | 20.31 cm^3 STANDARD_DEVIATION 38.604 | 16.41 cm^3 STANDARD_DEVIATION 29.66 |
| Definitive surgical debridement prior to enrollment no | 0 Participants | 0 Participants | 0 Participants |
| Definitive surgical debridement prior to enrollment yes | 86 Participants | 83 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 83 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 86 Participants | 83 Participants | 169 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 65 Participants | 68 Participants | 133 Participants |
| Wound age (days) | 27.66 days STANDARD_DEVIATION 29.798 | 24.44 days STANDARD_DEVIATION 31.237 | 26.08 days STANDARD_DEVIATION 30.456 |
| Wound etiology/type Diabetic Ulcer | 3 Participants | 3 Participants | 6 Participants |
| Wound etiology/type other | 0 Participants | 3 Participants | 3 Participants |
| Wound etiology/type Pressure Ulcer | 0 Participants | 0 Participants | 0 Participants |
| Wound etiology/type Surgical Dehisced | 15 Participants | 22 Participants | 37 Participants |
| Wound etiology/type Traumatic | 68 Participants | 55 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 85 |
| other Total, other adverse events | 34 / 84 | 36 / 85 |
| serious Total, serious adverse events | 0 / 84 | 1 / 85 |
Outcome results
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)
Time frame: over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device: V.A.C. VERAFLO™ Dressing Kit | Wound Volume Reduction Rate (Unit: %) | 62.15 percentage of baseline wound volume | Standard Deviation 43.485 |
| Comparator Device: Negative Pressure Wound Drainage Material | Wound Volume Reduction Rate (Unit: %) | 65.04 percentage of baseline wound volume | Standard Deviation 40.088 |
95% CI: [-14.3, 16.07]
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.
Time frame: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Investigational Device: V.A.C. VERAFLO™ Dressing Kit | Time to Completion of Wound Bed Preparation (Unit: Day) | 9.0 days |
| Comparator Device: Negative Pressure Wound Drainage Material | Time to Completion of Wound Bed Preparation (Unit: Day) | 9.0 days |
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)
Time frame: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device: V.A.C. VERAFLO™ Dressing Kit | Wound Area Reduction Rate (Unit: %) | 19.21 percentage of baseline wound area | Standard Deviation 23.267 |
| Comparator Device: Negative Pressure Wound Drainage Material | Wound Area Reduction Rate (Unit: %) | 27.20 percentage of baseline wound area | Standard Deviation 21.439 |
p-value: 0.24ANCOVA