Chitosan Unguent in burned patients

Phase 2

Conditions: Superficial first and second degree burns
Burns
Wounds and Injuries

Registration Number: RPCEC00000256

Lead Sponsor: Center for Pharmaceutical Research and Development, Havana, Cuba.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

Inclusion Criteria

1- Cuban patients, of any sex, any skin color, with superficial burns, grades I and II.
2- Ages between 18 and 70 years, both inclusive.
3 - Burns by physical agents.
4- Written informed consent of the patient to participate in the investigation and to complete the established examinations.

Exclusion Criteria

1- Burns from electrical or chemical origin, by inhalation or combined.
2 - Presence of microbiologically confirmed sepsis in the lesions, caused by Pseudomonas aeruginosa or other bacterial agents.
3- History of allergy or hypersensitivity to any component of the formulation.
4- Diabetes mellitus.
5- Referred immunological disease.
6- Malignant disease.
7- Collagen disease.
8- Pregnancy, breastfeeding or puerperium.
9- Severe psychiatric disorder or mental incapacity.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of lesions healing (Time from baseline assessment until the moment of total healing of the lesions or the moment of formation of useful granulation tissue in the affected area). Measurement time: daily during the duration of the treatment.

Secondary Outcome Measures

Name	Time	Method
1. Extension of lesions (It will calculate using a simple method named Kirschbaum Rule or rule of 3, which constitutes a modification of the Wallace Rule (or rule of 9), by which it is considered that Different bodily anatomical regions represent 9% each or a multiple of 9% of total body surface area). Measurement time: at baseline and, then at days 7 and 14 of treatment or until the time of healing of the lesions.<br>2. Presence of local adverse events-AE (distribution frequency for the appearance of AE (Yes, No), type of event (name of the AE), duration (time from appearance until stop the event), severity (severe, non-severe), intensity of AE (grades 1-5), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration until the end of treatment.<br>