Wound CareNCT01048307
Effect of Prontosan Wound Irrigation Solution on Venous Ulcers
A study testing Prontosan wound irrigation solution in people with Wound Care and Venous Ulcer Care, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial summary
Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled multi-centre, prospective clinical trial Planned number of subjects: 20 patients in… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Wound Care, Venous Ulcer Care, Wound Cleansing
- What is being tested?
- Prontosan wound irrigation solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females aged at least 18 with wounds of venous aetiology (documented by targeted exams) located in the lower limbs
- Ankle Brachial Index (ABI) ≥ 0.7
- patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic) over the 30 days before joining the study
Who cannot join
- age below 18 years
- presence of clinical infection, or current use of antiseptics or antibiotics
- chronic wounds of long duration (>30cm2 and >1 year duration)
- involvement in other wound related trials within the past 30 days
- sensitivity to any of the components of Prontosan® or dressing material
- intolerance to compression therapy
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- active osteomyelitis in the ulceration area
- active rheumatoid arthritis (RA) requiring any immunosuppressive therapy
- collagen vascular disease active treated with steroids
- chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
- plasma protein below 4 g/dl
- anaemia: haemoglobin below 10 g/dl
- both, controlled and uncontrolled diabetics (type 1 or 2)
- patients on any rheological agents (not including aspirin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Calvary hospital center for curative and palliative wound care
The Bronx, New York, 10461
About this study
Official title: Randomised, Controlled, Clinical Trial on the Safety and Efficacy of Prontosan Wound Irrigation Solution Compared to Standard Therapy in the Treatment of Hard-to-Heal Venous Leg Ulcers
Objective:
To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution
Methodology:
Randomised, controlled multi-centre, prospective clinical trial
Planned number of subjects:
20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline)
Products under investigation:
Prontosan® Wound Irrigation Solution
Study Duration:
3-4 weeks
Read the detailed description
Investigational product, dose and administration:
Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group) will be applied at inclusion and reapplied after dressing changes.
The treatment scheme is as follows:
- Prontosan® Wound Irrigation Solution (experimental group):
- cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the immediate wound in the form of a moist compress and removed after approximately 15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
- Saline (control group):
- cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
Dressings will be changed and the treatment procedure will be repeated in the clinic 2x/weekly or more. The efficacy of the treatment procedure will be evaluated on the basis of a 2 week observation period.
Treatment efficacy assessment:
- Assessment of clinical signs and symptoms at entry to the study and after one and two weeks.
- Quantitative and qualitative microbiological analysis at entry to the study and after two weeks.
- Wound planimetry using PictZar® CDM at entry to the study and after two weeks.
Primary aim:
- clinical signs assessed by:
- reduction of slough and necrotic tissue
- control of exudate
- presence of granulation tissue
- reduction of inflammatory signs (surrounding skin)
- reduction in wound size (assessed by wound planimetry)
- reduction of bacterial load (quantitative and qualitative microbiological
Secondary aim:
- tolerance and safety assessment:
- adverse drug reaction
- adverse events
- early withdrawal from the study
- Conditions
- Wound Care, Venous Ulcer Care, Wound Cleansing, Chronic Wound Care
- Being tested
- Prontosan wound irrigation solution
- Keywords
- prontosan, wound cleansing, wound irrigation, phmb, polihexanide, betaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prontosan wound irrigation solutionDevice
Also called Wound irrigation solution containing PHMB, Polihexanide, Betaine, Wound cleanser
Prontosan® Wound Irrigation Solution (experimental group):
- Active ingredients (Polihexanide 0.1%, Betaine 0.1%) cleansing the wound bed at dressing change with Prontosan® Wound
Saline (control group):
- cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
| Study group | Role | What they receive |
|---|---|---|
| Prontosan wound irrigation solution | Experimental | Prontosan® Wound Irrigation Solution (experimental group):
* cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
* placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution;
* fixing the dressing to the wound using multilayered elastic compression bandaging (Profore®bandaging system). Receives: Device: Prontosan wound irrigation solution |
| Saline irrigation (standard care control) | Placebo comparator | Saline (control group):
* cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
* placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
* fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system). Receives: Device: Prontosan wound irrigation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score)
Measured: weekly
Secondary outcomes (1)
Adverse device effect (s) Adverse events
Measured: volunteered at any time or during weekly evaluation visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Medical SA
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Calvary Hospital, Wound CareMartin Wendelken, RN, DPM, Study director, Calvary Hospital, Wound Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048307
- Sponsor's protocol ID
- OPM-I-H-0902
- Status last verified
- Aug 2010
- First submitted
- 12 Jan 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Clinical Trial on the Safety and Efficacy of Prontosan Wound Irrigation Solution Compared to Standard Therapy in the Treatment of Hard-to-Heal Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01048307
- Acronym / sponsor ID
- OPM-I-H-0902
- Conditions
- Wound Care, Venous Ulcer Care, Wound Cleansing, Chronic Wound Care
- Keywords
- prontosan, wound cleansing, wound irrigation, phmb, polihexanide, betaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Collaborators
- B. Braun Medical SA
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution
Methodology:
Randomised, controlled multi-centre, prospective clinical trial
Planned number of subjects:
20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline)
Products under investigation:
Prontosan® Wound Irrigation Solution
Study Duration:
3-4 weeks
Detailed description
Investigational product, dose and administration:
Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group) will be applied at inclusion and reapplied after dressing changes.
The treatment scheme is as follows:
- Prontosan® Wound Irrigation Solution (experimental group):
- cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the immediate wound in the form of a moist compress and removed after approximately 15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
- Saline (control group):
- cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;
- placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;
- fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).
Dressings will be changed and the treatment procedure will be repeated in the clinic 2x/weekly or more. The efficacy of the treatment procedure will be evaluated on the basis of a 2 week observation period.
Treatment efficacy assessment:
- Assessment of clinical signs and symptoms at entry to the study and after one and two weeks.
- Quantitative and qualitative microbiological analysis at entry to the study and after two weeks.
- Wound planimetry using PictZar® CDM at entry to the study and after two weeks.
Primary aim:
- clinical signs assessed by:
- reduction of slough and necrotic tissue
- control of exudate
- presence of granulation tissue
- reduction of inflammatory signs (surrounding skin)
- reduction in wound size (assessed by wound planimetry)
- reduction of bacterial load (quantitative and qualitative microbiological
Secondary aim:
- tolerance and safety assessment:
- adverse drug reaction
- adverse events
- early withdrawal from the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prontosan wound irrigation solution | Experimental | Device: Prontosan wound irrigation solutionProntosan® Wound Irrigation Solution (experimental group): * cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore®bandaging system). |
| Saline irrigation (standard care control) | Placebo comparator | Device: Prontosan wound irrigation solutionSaline (control group): * cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females aged at least 18 with wounds of venous aetiology (documented by targeted exams) located in the lower limbs
- Ankle Brachial Index (ABI) ≥ 0.7
- patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic) over the 30 days before joining the study
Key exclusion criteria (14 listed)
- age below 18 years
- presence of clinical infection, or current use of antiseptics or antibiotics
- chronic wounds of long duration (>30cm2 and >1 year duration)
- involvement in other wound related trials within the past 30 days
- sensitivity to any of the components of Prontosan® or dressing material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prontosan wound irrigation solutionAlso: Wound irrigation solution containing PHMB, Polihexanide, Betaine, Wound cleanserProntosan® Wound Irrigation Solution (experimental group): • Active ingredients (Polihexanide 0.1%, Betaine 0.1%) cleansing the wound bed at dressing change with Prontosan® Wound Saline (control group): * cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system). | Device | Prontosan wound irrigation solution, Saline irrigation (standard care control) |
Primary outcome
Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score)
Time frame: weekly
1 secondary outcome
Adverse device effect (s) Adverse events
Time frame: volunteered at any time or during weekly evaluation visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar M Alvarez, PhD principal investigator
Calvary Hospital, Wound Care
Martin Wendelken, RN, DPM study director
Calvary Hospital, Wound Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prontosan wound irrigation solution in people with Wound Care and Venous Ulcer Care, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score) (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2010.