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

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.

Study Overview

• Status: Unknown
• Conditions: Non-healing Wound; Infected Wound
• Intervention / Treatment: Device: latent available chlorine (LAC)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Males and females above the age of 18

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
latent available chlorine (LAC); applying LAC on infected wounds	Device: latent available chlorine (LAC); local application on the necrotic infected tissue; Other Names: K-sept

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (ACTUAL): February 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Safety Issue
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: Any unique identifier assigned

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No