Trial Outcomes & Findings for A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies (NCT NCT00605189)
NCT ID: NCT00605189
Last Updated: 2024-10-16
Results Overview
Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 \* ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Day 0, Day 2, Day 7
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
VAC NPWT
Powered Suction Pump (VAC Freedom): continuous suction, foam based negative pressure wound therapy
|
Gauze-Based NPWT
Powered Suction Pump: continuous suction; gauze based negative pressure wound therapy
|
Moist Wound Therapy
MWT: moist wound therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
9
|
|
Overall Study
COMPLETED
|
17
|
19
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
VAC NPWT
Powered Suction Pump (VAC Freedom): continuous suction, foam based negative pressure wound therapy
|
Gauze-Based NPWT
Powered Suction Pump: continuous suction; gauze based negative pressure wound therapy
|
Moist Wound Therapy
MWT: moist wound therapy
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Other
|
2
|
2
|
0
|
Baseline Characteristics
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
Baseline characteristics by cohort
| Measure |
VAC NPWT
n=20 Participants
Powered Suction Pump (VAC Freedom): continuous suction
|
Gauze-Based NPWT
n=21 Participants
Powered Suction Pump: continuous suction
|
Moist Wound Therapy
n=9 Participants
MWT: moist wound therapy
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other, not specified
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 2, Day 7Population: Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above.
Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 \* ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
Outcome measures
| Measure |
VAC NPWT
n=11 Participants
Powered Suction Pump (VAC Freedom): continuous suction
|
Gauze-Based NPWT
n=8 Participants
Powered Suction Pump: continuous suction
|
Moist Wound Therapy
n=9 Participants
MWT: moist wound therapy
|
|---|---|---|---|
|
Compare Energy Charge Between Wound Treatment Therapies
Day 0
|
0.4732 Ratio
Standard Deviation 0.0333
|
0.5607 Ratio
Standard Deviation 0.1586
|
0.4873 Ratio
Standard Deviation 0.0310
|
|
Compare Energy Charge Between Wound Treatment Therapies
Day 2
|
0.4601 Ratio
Standard Deviation 0.1399
|
0.5535 Ratio
Standard Deviation 0.1377
|
0.4927 Ratio
Standard Deviation 0.0379
|
|
Compare Energy Charge Between Wound Treatment Therapies
Day 7
|
0.5289 Ratio
Standard Deviation 0.1395
|
0.5322 Ratio
Standard Deviation 0.1510
|
0.5022 Ratio
Standard Deviation 0.0220
|
Adverse Events
VAC NPWT
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Gauze-Based NPWT
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Moist Wound Therapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAC NPWT
n=20 participants at risk
Powered Suction Pump (VAC Freedom): continuous suction
|
Gauze-Based NPWT
n=21 participants at risk
Powered Suction Pump: continuous suction
|
Moist Wound Therapy
n=9 participants at risk
MWT: moist wound therapy
|
|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
10.0%
2/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Infections and infestations
Infected Skin Ulcer
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Infections and infestations
Wound Infection
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • 30 days
|
4.8%
1/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Investigations
Haemaglobin decreased
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
Other adverse events
| Measure |
VAC NPWT
n=20 participants at risk
Powered Suction Pump (VAC Freedom): continuous suction
|
Gauze-Based NPWT
n=21 participants at risk
Powered Suction Pump: continuous suction
|
Moist Wound Therapy
n=9 participants at risk
MWT: moist wound therapy
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Maceration
|
10.0%
2/20 • 30 days
|
14.3%
3/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Skin and subcutaneous tissue disorders
Panniuculitis
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
22.2%
2/9 • 30 days
|
|
Infections and infestations
Wound Infection
|
10.0%
2/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Infections and infestations
Localised Infection
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Infections and infestations
Staphylococcal Infection
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
General disorders
Pyrexia
|
5.0%
1/20 • 30 days
|
4.8%
1/21 • 30 days
|
22.2%
2/9 • 30 days
|
|
General disorders
Chills
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
22.2%
2/9 • 30 days
|
|
General disorders
Chest Pain
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • 30 days
|
9.5%
2/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
22.2%
2/9 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
22.2%
2/9 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Injury, poisoning and procedural complications
Wound Complication
|
10.0%
2/20 • 30 days
|
14.3%
3/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Investigations
Urine Output Decreased
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Investigations
Red Cell Distribution Width Increased
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Metabolism and nutrition disorders
Shock Hypoglycaemic
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Surgical and medical procedures
Wound Drainage
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/20 • 30 days
|
0.00%
0/21 • 30 days
|
11.1%
1/9 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.0%
1/20 • 30 days
|
0.00%
0/21 • 30 days
|
0.00%
0/9 • 30 days
|
Additional Information
Senior Director, Global Clinical Development
KCI, an Acelity Company
Phone: 210-255-5595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60