Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Control Intervention1: topical gel: deoxyribonucleic acid gyrase/topoisomerase IV inhibitor and immunomodulatory agent
Sponsors
Dr. Prashant Prakash Lad
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female subjects aged above 9 years old with a diagnosis of malodorous malignant fungating wound malodor corresponding to 0,1 and 2 on the TELER odor scale where 0 Malodor detected upon entering room above 3m or above 10ft with dressing on 1 Malodor detected at above 2m above 3m between 6 to 10ft distance from patient with dressing on and 2 Malodor detected at 1m or arm s length to the patient with dressing on, as judged by the investigators 2 Signed informed consent for adults For subjects under 16 years of age a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form or equivalent if applicable, approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC) Whenever practical and appropriate per local requirements a child’s assent should also be sought before inclusion into the study 3 An Eastern Cooperative Oncology Group (ECOG) performance status of =3; 4 An anticipated survival of above 3 months
Exclusion criteria
Exclusion criteria: 5 Patients who are likely to respond to chemotherapy or radiation therapy. 6 Patients with current bleeding in wounds. 7 Subjects currently being treated with any antibiotic for bacterial infections or suffering from any infection that may require systemic antibiotic. 8 Patient is above 9 years of age at the time of informed consent 9 Life expectancy of below 3 months. 10 The patient is not an appropriate candidate for participation in this clinical study for any other reason as deemed by the investigator. 11 Subjects with known hypersensitivity to fluoroquinolones 12 Patients with serious cardiovascular diseases hemodyscrasia predisposition to arrhythmias (eg QT-interval prolongation, uncorrected hypokalemia or hypomagnesemia, significant bradycardia) 13 Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol 14 Nursing mothers pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: 1. Mean score of malodor associated with malignant fungating wounds (scored by investigators) using a 6 point TELER Scale on Day 14.Timepoint: Primary Efficacy Endpoint: 1. Mean score of malodor associated with malignant fungating wounds (scored by investigators) using a 6 point TELER Scale on Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy Endpoints: 5. Mean score of malodor scored by the patient at Day 7 and 14 using a TELER Component scale. 6. Mean score of malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 7.Timepoint: Key Secondary Efficacy Endpoints: 5. Mean score of malodor scored by the patient at Day 7 and 14 using a TELER Component scale. 6. Mean score of malodor associated with malignant fungating wounds (scored by investigators) using a 6-point TELER Scale at Day 7. | — |
Countries
India
Contacts
Public ContactDr Prashant P Lad
Om Sai onco Surgery Center .
Outcome results
None listed