The Use of Klorsept Solution for Debriding Infected Wounds: is it Effective and Safe? Prospective Observational Study

Study Overview
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Brief Summary
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Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The aim of this study is to elaborate the effectiveness and safety of this solution.

Detailed Description
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Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The aim of this study is to elaborate the effectiveness and safety of this solution. This study will include 50 patients suffering from necrotic and infected wounds. Several parameters will be evaluated in order to provide the effectiveness and safety of this treatment.

Official Title
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The Use of Klorsept Solution for Debriding Infected Wounds: is it Effective and Safe? Prospective Observational Study

Conditions
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Non-healing Wound, Infected Wound

Intervention / Treatment
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* Device: latent available chlorine (LAC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized patients with infected wounds who can sign an informed consent Exclusion Criteria: patient that can not sign an informed consent pregnant woman age less than 18 years Allergy to chlorine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| latent available chlorine (LAC)<br>applying LAC on infected wounds | Device: latent available chlorine (LAC)<br>* local application on the necrotic infected tissue<br>* Other names: K-sept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antiseptic properties | General outcome: Pain will be assessed by the VAS scale. Score above 3 will be considered an abnormal value. Fever ( in C0) above 37.5 an abnormal value. Pulse rate elevated from the baseline patient by 15% will be an abnormal value. Systolic Blood pressure elevated from the baseline of the patient by 15% will be an abnormal value. Number of breathing which will be elevated from the baseline of the patient by 15% will be an abnormal value. Saturation which will be reduced by 5% from the baseline will be an abnormal value. Local Outcome: redness/ edema /odor/discharge will be evaluated by a score from 0 to 3 (0- no redness/edema/odor/discharge ; 3- severe redness /edema/odor/discharge). Skin eruption will be evaluated as no/yes. The results will be aggregated to arrive at one reported value (e.g., Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory tests | laboratory tests: Glucose: values that are above 100 mg/dl (not with diabetic patients) Albumin: values that are less than 3.5 g/dl Creatinine: values that are above 1.17 mg% Urea: values that are above 43 mg% Sodium: values that are under 135 mEq/l or above 145 mEq/l Potassium: values that are under 3.5 mEq/l or above 5.1 mEq/l White blood count: values that are above 10.80 k/ul C- reactive protein: values that are above 0.5 mg/dl The results will be aggregated to arrive at one reported value (e.g., Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety Issue