Dermosep-I

Phase 1

• Conditions: Septic burns.; Burns; Sepsis; Wounds and Injuries; Infection

• Registration Number: RPCEC00000040
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Cuban patients, of both sexes and any race, with burns type A, AB or B, classified as slight, moderate or serious, requiring occlusion. Presence of sepsis, microbiologically confirmed in lesions, caused by Pseudomonas aeruginosa or any other bacterial agents. Patients aged 16 to 60. Burns by physical agents. Patient’s Informed Consent in writing to participate in the trial and undergo relevant tests.

Exclusion Criteria

Burns by electrical or chemical agents, inhalation, or both. Burns in anal and genital region, and face. Systemic or topical anti-microbial required. Patients who have been on steroid treatment in the last 3 months (any administration route). History of allergy or hypersensitivity to any formulation component. Diabetes mellitus. Immune disease diagnosed. Malignant neoplasia. Chronic kidney failure or liver disorder. Collagen disease. Pregnancy, breastfeeding or puerperium. Severe psychiatric disorder or mental handicap.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment safety, measuring time: 28 days.

Secondary Outcome Measures

Name	Time	Method
Clinical and microbiological response to sepsis, measuring time: 28 days. Negative microbiological test, measuring time: 28 days. Sepsis elimination, measuring time: 28 days. Lesion cicatrization: measuring time: 28 days. Lesion size: measuring time: 28 days