Dermosep-I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000040
• Date of registration: 20/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City
• Public title: Dermosep-I
• Scientific title: Application of Dermofural ointment in patients with septic burns.
• Date of first enrolment: 02/05/2008
• Target sample size: 20
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000040-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Idrian Garcia Garcia
• Affiliation: Clinical Trials Division, Center for Biological Research

• Name: MSc. Idrian Garcia Garcia
• Affiliation: Clinical Trials Division, Center for Biological Research

Key inclusion & exclusion criteria

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.

Age minimum: 16 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Septic burns.

Intervention(s)

One single group will have lesions treated with Dermofural ointment once a day, after bandage removal and wound bath. Depending on the patient’s clinical and microbiological evolution, Dermofural can be applied for up to 14 days or less if wounds heal up earlier. For relapse prevention, patients suffering from no sepsis will have the product applied one every other day, from the 14th to the 28th day, or until wounds heal up.

Primary Outcome(s)

Treatment safety, measuring time: 28 days.

Secondary Outcome(s)

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

Secondary ID(s)

IG/DFU/QM/0501

Source(s) of Monetary Support

Ministry of Public Health(MINSAP).

Secondary Sponsor(s)

Chemical Bioactive Center. ''Marta Abreu'' Central University of Las Villas