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

NCT03592498 | Completed Phase 2

• 1 other identifier: Pele de tilápia
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Burns

Keywords

Burns; Wounds and Injuries; Biocompatible Materials; Nile Tilapia; Oreochromis niloticus.

Outcome Measures

Primary Outcomes (6)

• 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

• Number of days for complete re-epithelization in study C

  Number of days until complete re-epithelialization observed by the evaluator

  Day 21

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in scale of pain by the Visual Analogue Scale

  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).

• Change in Global Clinical Impression Scale - Disease Severity (CGI-S) scores

  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).

• Change in Global Clinical Impression Scale - Disease Improvement (CGI-I) scores

  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).

• Change in patient global assessment scores

  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).

Study Arms (2)

Sulfadiazine, Silver

ACTIVE COMPARATOR

Intervention: Treatment with silver sulfadiazine ointment. Procedures: wound washing, application of silver sulfadiazine ointment, bandage covered with gauze and bandage. These patients undergone the change of dressings on alternate days.

Drug: Sulfadiazine, Silver

Skin of Nile tilapia

EXPERIMENTAL

Intervention: treatment with skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing. Procedures: wound washing, application of tilapia skin and dressing with gauze and bandage. These dressings were changed if the skin of the tilapia was loose (not adhered).

Device: Skin of Nile tilapia

Interventions

Sulfadiazine, Silver DRUG

Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.

Sulfadiazine, Silver

Skin of Nile tilapia DEVICE

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

Skin of Nile tilapia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara: lead

Related Publications (2)

• Alves APNN, Lima Junior EM, Piccolo NS, de Miranda MJB, Lima Verde MEQ, Ferreira Junior 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 Sep;19(3):373-382. doi: 10.1007/s10561-017-9681-y. Epub 2018 Jan 29.

  PMID: 29380095 BACKGROUND

• Lima Junior EM, De Moraes Filho MO, Costa BA, Rohleder AVP, Sales Rocha MB, Fechine FV, Forte AJ, Alves APNN, Silva Junior FR, Martins CB, Mathor MB, Moraes MEA. Innovative Burn Treatment Using Tilapia Skin as a Xenograft: A Phase II Randomized Controlled Trial. J Burn Care Res. 2020 May 2;41(3):585-592. doi: 10.1093/jbcr/irz205.

  PMID: 31900475 DERIVED

Related Links

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

MeSH Terms

Conditions

Burns; Wounds and Injuries

Interventions

Silver Sulfadiazine

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Maria Elisabete A Moraes, MD

  Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Plastic Surgeon

Model Details: Clinical study Phase II, pilot, open, monocentric and randomized.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 19, 2018
• Study Start: October 5, 2016
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share