Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds

Burns Clinical Trial

Official title:

Randomised Clinical Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), as an Occlusive Biological Dressing, in the Treatment of Burn Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592498
• Other study ID #: Pele de tilápia
• Status: Completed
• Phase: Phase 2
• Start date: October 5, 2016
• Est. completion date: September 20, 2017

Study information

• Verified date: July 2018
• Source: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomised Clinical Study to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing, in the treatment of humans burn wounds.

Description:

This was a randomized, monocentric; open-label pilot clinical study conducted at the Dr. José Frota Institute's Burn Treatment Center, located in Fortaleza, Ceará, Brazil, from October 2016 to September 2017.

The study participants were recruited from the population of patients attending the Burning Treatment Center of the Dr. José Frota Institute. Were included female and male participants, age range greater than or equal to 18 and greater than or equal to 50 years old and who met the following criteria: presence of a dermatological wound caused by superficial second-degree burn with up to 20% of the body surface or deep second degree with area of 5 to 15% of the body surface; absence of previous treatment for the current burn and without other significant diseases that could impact their participation in the study. No study participants were known to have hypersensitivity to materials used in the study or to related compounds; history of serious adverse reactions; addiction to drugs, including alcohol; pregnancy and labor or miscarriage in the 12 weeks prior to the scheduled start of treatment.

The study was divided according to the depth and burned body surface area of the research participant:

Study A: Burning of 2nd Surface Degree with <10% of body surface area - Patients in outpatient care, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia).

Study B: 2nd Degree Burn with 10 to 20% body surface area - Inpatient, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia).

Study C: Deep 2nd Degree Burn with 5 to 15% body surface area - Inpatient, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia).

Interventions:

Participants were randomly assigned to the following treatments:

• Experimental intervention: use of the skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing;

• Active comparator intervention: Conventional treatment with silver sulfadiazine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Presence of a dermatological wound caused by superficial second-degree burn with up to 20% of the body surface or deep second degree with area of 5 to 15% of the body surface;

• Absence of previous treatment for the current burn

• Without other significant diseases that could impact their participation in the study

Exclusion Criteria:

• Hypersensitivity to materials used in the study or to related compounds;

• History of serious adverse reactions;

• Addiction to drugs, including alcohol;

• Pregnancy

• Labor or miscarriage in the 12 weeks prior to the scheduled start of treatment.

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Sulfadiazine, Silver
Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.

Device:
• Skin of Nile tilapia
Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

References & Publications (1)

Alves APNN, Lima Júnior EM, Piccolo NS, de Miranda MJB, Lima Verde MEQ, Ferreira Júnior AEC, de Barros Silva PG, Feitosa VP, de Bandeira TJPG, Mathor MB, de Moraes MO. Study of tensiometric properties, microbiological and collagen content in nile tilapia skin submitted to different sterilization methods. Cell Tissue Bank. 2018 Jan 29. doi: 10.1007/s10561-017-9681-y. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days for complete re-epithelization in study A and B	Number of days until complete re-epithelialization observed by the evaluator	Day 11
Primary	Number of days for complete re-epithelization in study C	Number of days until complete re-epithelialization observed by the evaluator	Day 21
Primary	The number of dressings performed as needed in study A and B	Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.	Day 11
Primary	The number of dressings performed as needed in study C	Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.	Day 21
Primary	Amount of anesthetics or analgesics used throughout the treatment in study A and B	Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.	Day 11
Primary	Amount of anesthetics or analgesics used throughout the treatment in study C	Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.	Day 21
Secondary	Change in scale of pain by the Visual Analogue Scale	The visual Analogue scale consists of assisting in the assessment of pain intensity in the patient, being an important instrument to verify the evolution of the patient during the treatment. In each visit, the patient was instructed to respond as he rated his pain through scores ranging 0 to 10, where 0 to 2 meant mild pain, 3 to 7 meant moderate pain and 8 to 10 meant severe pain.	Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C).
Secondary	Change in Global Clinical Impression Scale - Disease Severity (CGI-S) scores	The evaluation of change in the scores of burn severity was performed by the physician during the study, using the global clinical impression scale - disease severity, which consistes of answering the following question - Considering your experience with this type of problem, what is the degree of severity of this patient's illness at the moment?? - Where, 0 means not evaluated, 1 - Much better, 2 - moderately better, 3 - Slightly better, 4 - unchanged, 5 - Slightly worse, 6 - Moderately worse and 7 - Much worse.	Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C).
Secondary	Change in Global Clinical Impression Scale - Disease Improvement (CGI-I) scores	The evaluation of change in the scores of burn improvement was performed by the physician during the study, using the global clinical impression scale - disease improvement, which consists of answering the following question - Compared to the initial state, how is the patient at this time? - Where, 0 means Not evaluated, 1 - Much better, 2 - moderately better, 3 - Slightly better, 4 - unchanged, 5 - Slightly worse, 6 - Moderately worse and 7 - Much worse.	Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C).
Secondary	Change in patient global assessment scores	The change in the patient burn-related symptoms was realized by answering the following question: Compared to the initial state, how is your disease-related symptoms at this time? - Where, 0 means much better, 1 - moderately better, 2 - Slightly better, 3 - unchanged, 4 - Slightly worse, 5 - Moderately worse and 6 - Much worse.	Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C).

External Links

•   Article about the tilapia skin
•   Article about the tilapia skin
•   Article about the tilapia skin