Ignite Creation Date:
2024-05-06 @ 3:52 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02394821
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2014-05-08
Brief Title:
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For odor control malignant wounds MW use is 08 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 02 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 08 versus 02 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 08 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 08 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 subjects 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
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 02 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 08 versus 02 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 08 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 08 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 subjects 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None