BurnsPhase 2NCT03592498
Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds
A Phase 2 study testing Sulfadiazine, Silver and Skin of Nile tilapia in people with Burns, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Burns
- What is being tested?
- Sulfadiazine, Silver and Skin of Nile tilapia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 20 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
Read the detailed 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.
- Conditions
- Burns
- Being tested
- Sulfadiazine, Silver, Skin of Nile tilapia
- Keywords
- Burns, Wounds and Injuries, Biocompatible Materials, Nile Tilapia, Oreochromis niloticus.
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadiazine, SilverDrug
Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.
Skin of Nile tilapiaDevice
Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Skin of Nile tilapia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days for complete re-epithelization in study A and B
Number of days until complete re-epithelialization observed by the evaluator
Measured: Day 11
Number of days for complete re-epithelization in study C
Number of days until complete re-epithelialization observed by the evaluator
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start5 Oct 2016
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical study Phase II, pilot, open, monocentric and randomized.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmar Maciel Lima Júnior, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Investigators
- Maria Elisabete A Moraes, MD, Study director, Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592498
- Sponsor's protocol ID
- Pele de tilápia
- Status last verified
- Jul 2018
- First submitted
- 25 May 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29380095Lima 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.
PubMed 31900475
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592498
- Acronym / sponsor ID
- Pele de tilápia
- Conditions
- Burns
- Keywords
- Burns, Wounds and Injuries, Biocompatible Materials, Nile Tilapia, Oreochromis niloticus.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do CearaUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical study Phase II, pilot, open, monocentric and randomized.
| Arm | Type | Receives |
|---|---|---|
| Sulfadiazine, Silver | Active comparator | Drug: Sulfadiazine, SilverIntervention: 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. |
| Skin of Nile tilapia | Experimental | Device: Skin of Nile tilapiaIntervention: 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfadiazine, SilverApplication of silver sulfadiazine ointment, bandage covered with gauze and bandage. | Drug | Sulfadiazine, Silver |
| Skin of Nile tilapiaApplication of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing. | Device | Skin of Nile tilapia |
Primary outcome
Number of days for complete re-epithelization in study A and B
Time frame: Day 11
Number of days until complete re-epithelialization observed by the evaluator
Number of days for complete re-epithelization in study C
Time frame: Day 21
Number of days until complete re-epithelialization observed by the evaluator
The number of dressings performed as needed in study A and B
Time frame: Day 11
Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.
The number of dressings performed as needed in study C
Time frame: Day 21
Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.
Amount of anesthetics or analgesics used throughout the treatment in study A and B
Time frame: Day 11
Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.
Amount of anesthetics or analgesics used throughout the treatment in study C
Time frame: Day 21
Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.
4 secondary outcomes
Change in scale of pain by the Visual Analogue Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Background: PubMed 29380095Alves 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.
- Derived from this study: PubMed 31900475Lima 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.
- Article about the tilapia skinLink provided by the sponsor.
- Article about the tilapia skinLink provided by the sponsor.
- Article about the tilapia skinLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elisabete A Moraes, MD study director
Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfadiazine, Silver and Skin of Nile tilapia in people with Burns, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days for complete re-epithelization in study A and B (time frame: Day 11). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.