Health Condition 1: null- Partial thickness burns
Conditions
Interventions
Intervention1: Xylentra: It is an Antimicrobial Peptide. Dose of study drug will be 4 gms per 1% burn. The drug will be topically administered once daily for 4 weeks or until complete wound healing, w
Sponsors
Issar Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Adult male or female patients aged 18- 60 years of age. • Patients with diagnosed (clinically) partial thickness thermal burn wounds. • Total surface area of the burn 10-20% by Wallace rule of Nine (Appendix 8) • Willing to give written informed consent. • Females of child-bearing potential with a negative urine or serum pregnancy test on admission and agrees to take suitable method of contraception for the duration of the study • Weight range within 20% of the ideal body weight as per standard tables and Indian criteria
Exclusion criteria
Exclusion criteria: • Patients with pulmonary burns • Patients with full thickness burns or deep partial thickness burn. • Patients who need skin grafting. • Patients with chemical or electrical burns. • Immune compromised patients. (patients taking immunosuppressive drugs such as glucocorticoids, alkylating agents, antimetabolites, antibodies, cyclosporin, tacrolimus, sirolimus, interferons, opioids, TNF binding proteins, Mycophenolate or any other biological agents) • Patients with history of chronic GI, renal, hepatic, respiratory, infectious, or History of allergy or hypersensitivity to investigational drugs or autoimmune disorders. • Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study • Known or newly diagnosed diabetics requiring insulin or oral anti diabetics. • Pregnant or breast-feeding female. • Known or suspected allergies to Xylentra• or silver sulfadiazine. • Participation in another investigational drug study within 30 days prior to treatment start • Patients with history of any topical or systemic antimicrobial drug for the current wound or taking antibiotics for co morbid condition • Patients suffering from any medical illnesses after burn which investigator thinks will endanger patientâ??s condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. Proportion of patients having complete closure/healing of the wounds during 28 days II. Proportion of patient with controlled secondary infection during 28 daysTimepoint: I. 1,4,6,8,10,12,14,16,18,20,22,24,26 and 28±1days II. 1, 4, 8, 12, 16, 20, 24 and 28 ±1days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of non-viable tissue by clinical evaluation % of wound covered with nonviable tissue (clinically) 2. Degree of granulation by visual Score % of wound filled with granulation tissue (clinically) 3. Wound Evaluation Done on Four Parameters (clinically) 4. Complete closure / healing of the wound (clinically). [Time Frame (in days): Admission to burn unit to 100% wound healing]Timepoint: 1,4,6,8,10,12,14,16,18,20,22,24,26 and 28±1days | — |
Countries
India
Contacts
Public ContactDr Srinivasa Rao
Seth GS Medical College & KEM Hospital
Outcome results
None listed