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Clinical Evidence

As part of assessing the safety and performance of RLS products, the company conducts clinical trials. A clinical trial involves involving subjects / patients in order to obtain clinical data on a medical device. A clinical trial must be approved by an Ethics Committee before it can start. If the clinical trial concerns a product that is not approved (eg CE marked), or if you want to examine an approved product for new indications the pharmaceutical authority in the country in question (eg the Medical Products Agency) must also approve the trial.

See pre-clinical evidence

CHLORASOLV01

ChloraSolv01 is an open, randomized, controlled multi-center study to evaluate the debridement effect of ChloraSolv on chronic wounds covered with devitalized tissue. The study was conducted at 9 centers in Sweden. The study shows additional data that confirm that debridement with ChloraSolv is effective and well tolerated by patients. The treatment lasted for only 5 weeks.

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The study shows additional data that confirm that debridement with ChloraSolv is effective and well tolerated by patients.

Reduction of devitalized tissue and wound reduction over time

%

Already after the first treatment, ther is a clear reduction of devitalized tissue. The reduction then continues for each week until last treatment. After 5 weeks of treatment, the devitalized tissue has decreased by about 73%.


The wound reduction appears, as expected, somewhat later than the reduction of devitalized tissue. After 5 weeks of treatment, the wound area has decreased by about 31%.

The Dolores study

The Dolores study is a prospective, randomized, open-label, controlled clinical trial. Four care facilities in the Gothenburg area, Sweden, participated in the study. ChloraSolv (under the working name Dermasolv) was compared with standard treatment in the treatment of infected diabetic foot ulcers.

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ChloraSolv has been evaluated on infected chronic diabetic foot ulcers in an open randomized controlled trial assessing reduction in wound area and time to healing as well as safety and tolerability. ChloraSolv treatment appears to be particularly effective in the early stages of treatment of infected diabetic foot ulcers.
Relative change in wound area per treatment group
Change in wound area %
Weeks

An early reduction in wound area was demonstrated during the first 7 weeks compared with standard treatment according to the International Working Group on the Diabetic Foot Guidelines.

Comparison of healing time
Number of healed wounds
Weeks
7 patients had healed wounds after 12 weeks compared to 3 in the group receiving standard treatment.

Pre-clinical Evidence

RLS continuously conducts development work where we produce laboratory data. To support new development ideas, we work with different types of laboratory models. Below you will find a selection of data in order to describe how ChloraSolv and our technology platform work.
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CHLORASOLVS EFFECT ON BACTERIA IN BIOFILM

The presence of biofilm in chronic wounds is a significant obstacle to treatment. The bacteria in biofilm protect themselves with a protective layer, which makes it difficult to reduce the amount of bacteria. The protective layer prevents antibiotics and other antiseptic treatments from reaching the bacteria. The effect of ChloraSolv has been tested on a biofilm model where we studied two of the most common wound bacteria.

CFU/ml (Log10)

A distinct decrease can be seen already after 30 seconds for both bacterial strains. At 2 and 5 minutes it is no longer possible to detect any bacteria. The killing of bacteria at those times is total.

Chemo-mechanical debridement with antimicrobial properties

ChloraSolv is based on a unique hypochlorite technology consisting of a two-component system, a gel containing amino acids and a sodium hypochlorite solution. The components are mixed in situ and form a gel that is applied directly to the wound. The system is designed to create an alkaline and oxidative environment during debridement while being non-irritant.
Strain
Log10 reduction
Escherichia coli
>5
Enterococcus hirae
>5
Pseudomonas aeruginosa
≥5
Staphylococcus aureus
>5
Candida albicans
≥5
Aspergillus brasiliensis
4
All tested microorganisms meet the criteria in Ph Eur 5.1.11 with a log10 reduction of at least 4 for fungal growth and at least 5 for bacteria. 1

COMPARISON BETWEEN CHLORASOLV AND PHMB ON BIOFILM, IN VITRO

The effect of ChloraSolv on bacteria in biofilm was compared with the effect of a frequently used washing solution consisting of PHMB. Comparisons of the effect between ChloraSolv and PHMB on bacteria in biofilm, in vitro, shows that ChloraSolv effectively eradicates the bacteria after 2 minutes. PHMB needs 15 minutes to achieve a distinct reduction3

Pseudomonas aeruginosa

CFU/ml (Log10)

Staphylococcus aureus

CFU/ml (Log10)

pH effect of ChloraSolv

The two ingredients are mixed when applied to the wound bed and cause a pronounced pH increase which helps to soften devitalized tissue. 5
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