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

NCT03049670 | Unknown

• 1 other identifier: Any unique identifier assigned
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-healing Wound; Infected Wound

Keywords

Safety Issue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• laboratory tests

  1 year

Study Arms (1)

latent available chlorine (LAC)

applying LAC on infected wounds

Device: latent available chlorine (LAC)

Interventions

latent available chlorine (LAC) DEVICE

local application on the necrotic infected tissue

Also known as: K-sept

latent available chlorine (LAC)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females above the age of 18

You may qualify if:

• hospitalized patients with infected wounds who can sign an informed consent

You may not qualify if:

• patient that can not sign an informed consent
• pregnant woman
• age less than 18 years
• Allergy to chlorine

Sponsors & Collaborators

• Carmel Medical Center: lead

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Plastic Surgery. Director, The Unit of Plastic Surgery

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: February 10, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 10, 2017

Record last verified: 2017-02