A Phase-III Clinical Trials of Xylentra Versus Silver Sulfadiazine for efficacy and safety in burnwound patients

Phase 3

Completed

• Conditions: Health Condition 1: null- Partial thickness burns

• Registration Number: CTRI/2012/04/002592
• Lead Sponsor: Issar Pharmaceuticals Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
I. Proportion of patients having complete <br/ ><br>closure/healing of the wounds during 28 days <br/ ><br> <br/ ><br>II. Proportion of patient with controlled secondary <br/ ><br>infection during 28 daysTimepoint: I. 1,4,6,8,10,12,14,16,18,20,22,24,26 and <br/ ><br>28±1days <br/ ><br> <br/ ><br>II. 1, 4, 8, 12, 16, 20, 24 and 28 ±1days.

Secondary Outcome Measures

Name	Time	Method
Extent of non-viable tissue by clinical evaluation <br/ ><br>% of wound covered with nonviable <br/ ><br>tissue (clinically) <br/ ><br> <br/ ><br> <br/ ><br>2. Degree of granulation by visual Score % of <br/ ><br>wound filled with granulation tissue <br/ ><br>(clinically) <br/ ><br> <br/ ><br>3. Wound Evaluation Done on Four Parameters <br/ ><br>(clinically) <br/ ><br> <br/ ><br>4. Complete closure / healing of the wound <br/ ><br>(clinically). [Time Frame (in days): Admission to <br/ ><br>burn unit to 100% wound healing]Timepoint: 1,4,6,8,10,12,14,16,18,20,22,24,26 and <br/ ><br>28±1days