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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03049670
Other study ID # Any unique identifier assigned
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 15, 2017
Last updated February 8, 2017
Start date March 1, 2017
Est. completion date March 1, 2018

Study information

Verified date February 2017
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Device:
latent available chlorine (LAC)
local application on the necrotic infected tissue

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Carmel Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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