Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasm; Wounds and Injuries
Intervention: Polihexanide 2% (Drug); Metronidazole 0.8% (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Sao Paulo
Summary
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 64 subjects divided into 2 groups (control - metronidazole group and experimental group -
PHMB ) , recruited in two cancer hospitals in the city of São Paulo ( ACCamargo Hospital and
Institute of Cancer of São Paulo ) , 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.
Clinical Details
Official title: Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide: Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Evaluate and compare the effectiveness of metronidazole solution 0.8% and polihexanide solution (PHMB) in odor control in malignant wounds. (odor scales)
Secondary outcome: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
EEUSP, São Paulo 01509-900, Brazil; Recruiting VERA CG SANTOS, PhD, Phone: 551130617533, Email: diana.villela@accamargo.org.br
Additional Information
Starting date: September 2013
Last updated: March 19, 2015
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