Trial Outcomes & Findings for Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds (NCT NCT05902793)
NCT ID: NCT05902793
Last Updated: 2025-03-11
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
86
|
|
Overall Study
COMPLETED
|
77
|
85
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds
Baseline characteristics by cohort
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=83 Participants
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=86 Participants
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).
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Definitive surgical debridement prior to enrollment
yes
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Definitive surgical debridement prior to enrollment
no
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline wound area (cm^2)
|
62.87 cm^2
STANDARD_DEVIATION 50.402 • n=5 Participants
|
50.16 cm^2
STANDARD_DEVIATION 43.570 • n=7 Participants
|
56.40 cm^2
STANDARD_DEVIATION 47.340 • n=5 Participants
|
|
Baseline wound volume (cm^3)
|
20.31 cm^3
STANDARD_DEVIATION 38.604 • n=5 Participants
|
12.61 cm^3
STANDARD_DEVIATION 16.264 • n=7 Participants
|
16.41 cm^3
STANDARD_DEVIATION 29.660 • n=5 Participants
|
|
Wound etiology/type
Traumatic
|
55 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Wound etiology/type
Surgical Dehisced
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Wound etiology/type
Pressure Ulcer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Wound etiology/type
Diabetic Ulcer
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Wound etiology/type
other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Wound age (days)
|
24.44 days
STANDARD_DEVIATION 31.237 • n=5 Participants
|
27.66 days
STANDARD_DEVIATION 29.798 • n=7 Participants
|
26.08 days
STANDARD_DEVIATION 30.456 • n=5 Participants
|
PRIMARY outcome
Timeframe: over 14 days or until deemed ready for closure by investigator (whichever occurred first)Population: Per Protocol Set
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)
Outcome measures
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=60 Participants
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=61 Participants
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).
|
|---|---|---|
|
Wound Volume Reduction Rate (Unit: %)
|
62.15 percentage of baseline wound volume
Standard Deviation 43.485
|
65.04 percentage of baseline wound volume
Standard Deviation 40.088
|
SECONDARY outcome
Timeframe: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)Population: Full analysis set
duration in days from the randomization until target wound ready for closure by secondary intervention judged by investigator.
Outcome measures
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=83 Participants
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=86 Participants
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).
|
|---|---|---|
|
Time to Completion of Wound Bed Preparation (Unit: Day)
|
9.0 days
Interval 9.0 to 10.0
|
9.0 days
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: Over 14 days or until deemed ready for closure by investigator (whichever occurred first)Population: Per Protocol Set
percent of total wound area change over 14 days or until deemed ready for closure by investigator (whichever occurred first)
Outcome measures
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=60 Participants
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=61 Participants
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).
|
|---|---|---|
|
Wound Area Reduction Rate (Unit: %)
|
19.21 percentage of baseline wound area
Standard Deviation 23.267
|
27.20 percentage of baseline wound area
Standard Deviation 21.439
|
Adverse Events
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Comparator Device: Negative Pressure Wound Drainage Material
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=84 participants at risk
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=85 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • Number of events 1 • up to 14 days
|
Other adverse events
| Measure |
Investigational Device: V.A.C. VERAFLO™ Dressing Kit
n=84 participants at risk
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).
|
Comparator Device: Negative Pressure Wound Drainage Material
n=85 participants at risk
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).
|
|---|---|---|
|
General disorders
Medical device site pain
|
7.1%
6/84 • up to 14 days
|
4.7%
4/85 • up to 14 days
|
|
General disorders
Pain
|
4.8%
4/84 • up to 14 days
|
7.1%
6/85 • up to 14 days
|
|
General disorders
Pyrexia
|
1.2%
1/84 • up to 14 days
|
3.5%
3/85 • up to 14 days
|
|
General disorders
Inflammation
|
1.2%
1/84 • up to 14 days
|
2.4%
2/85 • up to 14 days
|
|
General disorders
Hyperpyrexia
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
General disorders
Medical device site exfoliation
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Gastrointestinal disorders
Constipation
|
8.3%
7/84 • up to 14 days
|
7.1%
6/85 • up to 14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.0%
5/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Injury, poisoning and procedural complications
Skin injury
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
2/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/84 • up to 14 days
|
2.4%
2/85 • up to 14 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.4%
2/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Investigations
Blood pressure increased
|
1.2%
1/84 • up to 14 days
|
2.4%
2/85 • up to 14 days
|
|
Investigations
Blood glucose decreased
|
1.2%
1/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
2/84 • up to 14 days
|
2.4%
2/85 • up to 14 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Immune system disorders
Drug hypersensitivity
|
1.2%
1/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
1.2%
1/84 • up to 14 days
|
0.00%
0/85 • up to 14 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/84 • up to 14 days
|
1.2%
1/85 • up to 14 days
|
Additional Information
Dr. Zhijun Pan
The Second Affiliated Hospital of Zhejiang University School of Medicine
Phone: 0571-87783777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place