Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide

September 1, 2015 updated by: DIANA LIMA VILLELA DE CASTRO, University of Sao Paulo

Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide: Randomized Clinical Trial

For odor control malignant wounds (MW), use is 0.8% metronidazole solution - second recommendation scientific and clinical practice. But no this formulation available in Brazil , and its application to nursing steeps metronidazole tablets , diluted in saline and applied to the bed of (MW) . Thus , it is used off label for metronidazole ( tablets orally applied via " topical " - but it is not intact skin or mucosa ) , nursing and eventually manipulate the solution at bedside , and by law this power is pharmacist bedside and can not be taken .

Family antiseptic chlorhexidine was developed with the purpose of use in infected wounds called polihexanide ( PHMB ) . In Brazil is now available for hospital and home care ( 0.2 % Aquasept ® ) use. Evidence reported positive results in controlling infection of chronic wounds such as pressure ulcers . Although not tested its efficacy in odor control. Thus the study aims to compare metronidazole solution 0.8 % versus 0.2 % PHMB in odor control , where , if the results are favorable to PHMB we have a treatment option in odor control with ready to use formulation and easy access . Evaluate and compare the effectiveness of metronidazole solution 0.8% and polihexanide solution (PHMB) in odor control in MW. Aims: Evaluate and compare the time needed for odor control (reduction in days), using metronidazole and PHMB in MW (primary endpoint); Evaluate and compare the perceptions of patients, nurses and researcher on the odor MW, using metronidazole and PHMB in the MW; Evaluate and compare the pain reported by patients during dressing changes, using metronidazole and PHMB in the MW; Evaluate and compare the quality of life of patients before and after the use of metronidazole and PHMB in MW. This is a randomized, double -blind study with patients diagnosed with cancer and patients with MW with odor clinical trial . The sample consisted of 24 subjects divided into 2 groups (control - metronidazole group and experimental group - PHMB ) , recruited in one cancer hospital in the city of São Paulo (AC Camargo Cancer Center), which has as protocol description in odor control MW metronidazole . After acceptance by the subject and return the Statement of Informed Consent signed , randomization will be done .

For blinding , 0.8 % metronidazole solution will be provided by a compounding pharmacy (after stability testing of tablet diluted - and then stipulated expiration date) , and PHMB be bought from the supplier , delivered to the same compounding pharmacy which stores the PHMB in identical bottles to metronidazole ( only the responsible researcher will know to which group the subject was randomized ) .

The evaluation of the odor will be taken by 3 " employees " and the patient through 3 scales at zero , four, eight and twelve days ( or earlier if classified as " odorless " by 3 reviewers and the patient ) . Two scales about painful sensations in exchange for healing , one on quality of life will be applied to the patient and a specifically on the impact of odor on the subject's life.

To meet the proposed objectives, the data will be analyzed by: Friedman test to assess the odor reduction with respect to time; Mann-Whitney (or t test) for comparison of groups and the Fisher exact test to compare proportions. Data will be presented in the form of frequency tables for categorical variables and means, standard deviations and position measurements for quantitative variables. Will also be performed non-parametric analysis of ordinal data, or parametric analysis with Generalized Estimation Equation for binomial variables, depending on the data distribution and the sample size.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01509-900
        • EEUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of malignat wound with odor, regardless of location, etiology and tumor staging; well as in treatment or palliative care.
  • Confirmation of participation in the study by signing the Instrument of Consent, personally or through responsible caretaker

Exclusion Criteria:

  • not smell

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metronidazole
metronidazole 0.8% solution - topical
Drug: Metronidazole 0.8%
Experimental: Polihexanide
Polihexanide 2%
Drug: Polihexanide 2%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evaluate and compare the effectiveness of metronidazole solution 0.8% and polihexanide solution (PHMB) in odor control in malignant wounds. (odor scales)
Time Frame: 30/12/2014 (up to 1 year)
30/12/2014 (up to 1 year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate and compare the time required for odor control (reductions in days), using metronidazole and PHMB in malignant wounds (Friedman test to assess the odor reduction with respect to time)
Time Frame: 30/12/2014 (up to 1 year)
30/12/2014 (up to 1 year)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Evaluate and compare the perceptions of patients, nurses and researcher on the odor in malignant wounds, using metronidazole and PHMB in malignant wounds; (evaluation of odor scales [painful sensations in exchange for healing , and quality of life])
Time Frame: 30/12/2014 (up to 1 year)
30/12/2014 (up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EE-USP5571275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wounds and Injuries

Clinical Trials on Metronidazole 0.8%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings