Trial Outcomes & Findings for A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement (NCT NCT01867580)
NCT ID: NCT01867580
Last Updated: 2024-12-02
Results Overview
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Results posted on
2024-12-02
Participant Flow
Participant milestones
| Measure |
V.A.C.Ulta With Prontosan Instillation
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
88
|
|
Overall Study
COMPLETED
|
65
|
64
|
|
Overall Study
NOT COMPLETED
|
28
|
24
|
Reasons for withdrawal
| Measure |
V.A.C.Ulta With Prontosan Instillation
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Physician Decision
|
17
|
12
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Sponsor terminated study
|
1
|
0
|
|
Overall Study
Missed follow-up assessment
|
2
|
1
|
|
Overall Study
Interruption to therapy
|
3
|
0
|
|
Overall Study
Osteomyelitis
|
0
|
1
|
|
Overall Study
Continuation of therapy
|
0
|
1
|
|
Overall Study
Wound recurrence
|
0
|
1
|
Baseline Characteristics
A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
Baseline characteristics by cohort
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=93 Participants
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=88 Participants
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 13.92 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 14.25 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 14.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
112 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: until the wound is deemed ready for closure or coverage by the investigator up to 64 daysPopulation: Per-protocol population
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Outcome measures
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=71 Participants
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=66 Participants
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Number of Inpatient Operating Room Debridements
0 debridements
|
9 Participants
|
13 Participants
|
|
Number of Inpatient Operating Room Debridements
1 debridement
|
52 Participants
|
41 Participants
|
|
Number of Inpatient Operating Room Debridements
2 debridements
|
5 Participants
|
10 Participants
|
|
Number of Inpatient Operating Room Debridements
3 debridements
|
3 Participants
|
2 Participants
|
|
Number of Inpatient Operating Room Debridements
4 debridements
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately following initial post debridement to the first dressing change up to 72 hoursPopulation: Per-protocol population (some subjects had missing assessments)
Outcome measures
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=69 Participants
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=63 Participants
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
|
-0.18 Total Bacterial Counts (Log10 CFU)
Standard Deviation 2.15
|
0.6 Total Bacterial Counts (Log10 CFU)
Standard Deviation 2.01
|
POST_HOC outcome
Timeframe: until the wound is deemed ready for closure or coverage by the investigator up to 64 daysPopulation: This only included those patients with wound etiology of Surgically Dehisced Wounds
Outcome measures
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=10 Participants
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=9 Participants
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
3 debridements
|
0 Participants
|
2 Participants
|
|
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
4 debridements
|
0 Participants
|
0 Participants
|
|
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
0 debridements
|
3 Participants
|
1 Participants
|
|
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
1 debridement
|
7 Participants
|
2 Participants
|
|
Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds
2 debridements
|
0 Participants
|
4 Participants
|
Adverse Events
V.A.C.Ulta With Prontosan Instillation
Serious events: 19 serious events
Other events: 58 other events
Deaths: 3 deaths
V.A.C.Ulta Without Instillation
Serious events: 22 serious events
Other events: 44 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=93 participants at risk
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=88 participants at risk
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
2.2%
2/93
|
3.4%
3/88
|
|
Infections and infestations
Wound infection
|
1.1%
1/93
|
3.4%
3/88
|
|
Infections and infestations
Cellulitis
|
1.1%
1/93
|
2.3%
2/88
|
|
Infections and infestations
Sepsis
|
2.2%
2/93
|
0.00%
0/88
|
|
Infections and infestations
Abscess
|
1.1%
1/93
|
0.00%
0/88
|
|
Infections and infestations
Diabetic Foot Infection
|
1.1%
1/93
|
0.00%
0/88
|
|
Infections and infestations
Pneumonia
|
1.1%
1/93
|
0.00%
0/88
|
|
Infections and infestations
Purulent Discharge
|
1.1%
1/93
|
0.00%
0/88
|
|
Infections and infestations
Wound infection Staphylococcal
|
1.1%
1/93
|
1.1%
1/88
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/93
|
1.1%
1/88
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/93
|
1.1%
1/88
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
3.2%
3/93
|
2.3%
2/88
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
2.2%
2/93
|
3.4%
3/88
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/93
|
4.5%
4/88
|
|
Injury, poisoning and procedural complications
Post Porcedural Haemorrhage
|
1.1%
1/93
|
0.00%
0/88
|
|
Injury, poisoning and procedural complications
Failure of Implant
|
0.00%
0/93
|
1.1%
1/88
|
|
Vascular disorders
Phlebothrombosis
|
1.1%
1/93
|
1.1%
1/88
|
|
Vascular disorders
Wound Haemorrhage
|
1.1%
1/93
|
1.1%
1/88
|
|
Vascular disorders
Ischaemia
|
0.00%
0/93
|
2.3%
2/88
|
|
Vascular disorders
Hypotension
|
1.1%
1/93
|
0.00%
0/88
|
|
Vascular disorders
Peripheral Occlusive Disease
|
1.1%
1/93
|
0.00%
0/88
|
|
Vascular disorders
Haematoma
|
0.00%
0/93
|
1.1%
1/88
|
|
Nervous system disorders
Aphasia
|
1.1%
1/93
|
0.00%
0/88
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/93
|
0.00%
0/88
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/93
|
1.1%
1/88
|
|
Psychiatric disorders
Major Depression
|
1.1%
1/93
|
0.00%
0/88
|
|
Psychiatric disorders
Mental Status Changes
|
1.1%
1/93
|
0.00%
0/88
|
|
Psychiatric disorders
Aggression
|
0.00%
0/93
|
1.1%
1/88
|
|
Psychiatric disorders
Drug Dependence
|
0.00%
0/93
|
1.1%
1/88
|
|
Cardiac disorders
Cardiac Arrest
|
1.1%
1/93
|
0.00%
0/88
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/93
|
1.1%
1/88
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/93
|
1.1%
1/88
|
|
Gastrointestinal disorders
Peritonitis
|
1.1%
1/93
|
0.00%
0/88
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/93
|
1.1%
1/88
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/93
|
1.1%
1/88
|
|
Surgical and medical procedures
Amputation
|
1.1%
1/93
|
0.00%
0/88
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/93
|
1.1%
1/88
|
|
Investigations
Blood Glucose Fluctation
|
1.1%
1/93
|
0.00%
0/88
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/93
|
0.00%
0/88
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/93
|
1.1%
1/88
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/93
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/93
|
1.1%
1/88
|
|
Skin and subcutaneous tissue disorders
Skin Graft Failure
|
0.00%
0/93
|
1.1%
1/88
|
Other adverse events
| Measure |
V.A.C.Ulta With Prontosan Instillation
n=93 participants at risk
Treatment Arm
V.A.C.Ulta with instillation: NPWT with instillation of a wound cleanser
|
V.A.C.Ulta Without Instillation
n=88 participants at risk
Control Arm
V.A.C.Ulta without instillation: NPWT only
|
|---|---|---|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
28.0%
26/93
|
17.0%
15/88
|
|
Injury, poisoning and procedural complications
Wound Complication
|
10.8%
10/93
|
8.0%
7/88
|
|
Skin and subcutaneous tissue disorders
Skin Maceration
|
32.3%
30/93
|
19.3%
17/88
|
|
General disorders
Oedema
|
15.1%
14/93
|
9.1%
8/88
|
|
General disorders
Pain
|
6.5%
6/93
|
3.4%
3/88
|
|
Investigations
Glycosylated Haemoglobin Increased
|
4.3%
4/93
|
5.7%
5/88
|
|
Investigations
White Blood Cell Count Increased
|
5.4%
5/93
|
2.3%
2/88
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/93
|
8.0%
7/88
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60