Comparative study of Silver sulfadiazine cream (nanonized)and Silverex cream in burns wounds

Phase 2

Completed

• Conditions: Health Condition 1: null- Burns

• Registration Number: CTRI/2011/09/002030
• Lead Sponsor: Ranbaxy Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Subjects who have given written informed consent to participate in the study.

2. Subjects of either sex aged between 18 and 65 years (both inclusive) with partial thickness burns of thermal origin covering 10% of the TBSA and suitable for outpatient management.

3. Subjects in whom burn injury is 24 hours old at the time of screening.

4. Subjects with clean, non-infected wound as judged by the investigator.Presence of infection will be judged clinically by symptoms and signs that include purulent drainage, erythema, warmth, exudation, malodor, pain and/or fever.

Exclusion Criteria

1.Subjects with history of hypersensitivity to silver sulfadiazine, other sulfonamides, chlorhexidine or any of the excipients of study formulations#.

2.Subjects with burn wounds associated with chemical, electrical or inhalational injury.

3.Subjects with full thickness burns (a burn involving destruction of the entire epidermis and dermis, leaving no residual epidermal cells to repopulate) or circumferential burns (a burn which encircles an entire body part) or superficial burn (a burn which remains confined to the epidermis).

4.Subjects with burns involving genitalia, head (including face), perineum or major joints.

5.Subjects with burns of hands or feet likely to cause functional impairment.

6.Subjects with burn wounds not expected to heal within 21 days or requiring systemic antimicrobial treatment or surgical intervention (except surgical debridement) during the study.

7.Subjects with burn wounds expected to heal in less than 7 days.

8.Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.

9.Burn injury in subjects with preexisting medical disorders (e.g., diabetes mellitus, cancer or other immunocompromising conditions) that could complicate management, prolong recovery, or affect mortality.

10.Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.

11.Subjects with significant disease(s) or disorder(s) other than burn injury that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject?s ability to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified