Trial Outcomes & Findings for Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel (NCT NCT01153633)
NCT ID: NCT01153633
Last Updated: 2014-04-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
12 Weeks
Results posted on
2014-04-01
Participant Flow
Participant milestones
| Measure |
Prontosan Wound Solution and Gel
Polihexanide (0.1%), Betaine (0,1%), Purifed water
|
Normal Saline and Placebo Gel
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Prontosan Wound Solution and Gel
Polihexanide (0.1%), Betaine (0,1%), Purifed water
|
Normal Saline and Placebo Gel
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Therapeutic failure
|
3
|
3
|
Baseline Characteristics
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Baseline characteristics by cohort
| Measure |
Prontosan Wound Solution and Gel
n=17 Participants
Polihexanide (0.1%), Betaine (0,1%), Purifed water
|
Normal Saline and Placebo Gel
n=17 Participants
Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
71.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Duration of leg ulceration
|
36 months
n=5 Participants
|
84 months
n=7 Participants
|
54 months
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Per protocol set
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Percent Change of Wound Size From Baseline to Last Visit
|
-64.98 percentage change in wound size (cm2)
Standard Error 12.32
|
-42.78 percentage change in wound size (cm2)
Standard Error 13.13
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: per protocol analysis
Number of ulcers healed at V6/EOS
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Healing of Target Ulcer atV6/EOS
|
8 ulcers
|
5 ulcers
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: per protocol analysis
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Absolute Change of Target Ulcer From Baseline to Last Visit
|
-3.00 square centimeters
Standard Error 1.45
|
-3.01 square centimeters
Standard Error 1.54
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: per protocol analysis
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Number of Different Microganisms at V6/EoS
|
0.8 Number of microgasism species
Standard Deviation 0.9
|
1.0 Number of microgasism species
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: per protocol analysis
Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'.
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Pain
|
-8.9 mm
Standard Deviation 20.4
|
-12.8 mm
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: per protocol analysis
Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS
Outcome measures
| Measure |
Prontosan Wound Irrigation Solution and Gel
n=17 Participants
Polihexanide 0.1%, Betaine 01.%, purified water, exipients
|
Normal Saline and Inactive Gel
n=15 Participants
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Condition of Wound Bed
|
7.1 percentage of of wound bed
Standard Deviation 38.9
|
-1.5 percentage of of wound bed
Standard Deviation 52.0
|
Adverse Events
Prontosan Wound Solution and Gel
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Normal Saline and Placebo Gel
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prontosan Wound Solution and Gel
n=17 participants at risk
Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
|
Normal Saline and Placebo Gel
n=17 participants at risk
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Prontosan Wound Solution and Gel
n=17 participants at risk
Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
|
Normal Saline and Placebo Gel
n=17 participants at risk
Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
|
|---|---|---|
|
Infections and infestations
Celulitis
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Infected skin ulcer
|
29.4%
5/17 • Number of events 7
|
23.5%
4/17 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
29.4%
5/17 • Number of events 6
|
23.5%
4/17 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
5.9%
1/17 • Number of events 1
|
23.5%
4/17 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
5.9%
1/17 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.9%
1/17 • Number of events 2
|
17.6%
3/17 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
41.2%
7/17 • Number of events 11
|
35.3%
6/17 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Venous ulcer pain
|
5.9%
1/17 • Number of events 1
|
23.5%
4/17 • Number of events 4
|
|
Gastrointestinal disorders
Food poisoning
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
Additional Information
Medical Scientific Affairs Manager
B. Braun Medical AG
Phone: +41 58 258 55 47
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place