BurnsPhase 3NCT04202289
Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study
A Phase 3 study testing Nile Tilapia Fish Skin and Silver Sulfadiazine Cream 1% in people with Burns, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 2 sites in Brazil.
Trial summary
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- Nile Tilapia Fish Skin and Silver Sulfadiazine Cream 1%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 Apr 2017to 24 Oct 2018
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 and ≤60 years.
- Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
- Patient with indication for outpatient treatment.
Who cannot join
- Previous treatment for the current burn.
- Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
- Hypersensitivity to materials used in the study or to related compounds.
- History of severe adverse reactions; drug addiction, including alcohol.
- Use of medications that could have an impact on wound healing (e.g., steroids).
- Pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Burn Treatment Center, Dr. José Frota Institute
Fortaleza, Ceará, 60025-061
Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
Fortaleza, Ceará, 60430-275
About this study
Official title: Evaluation of Nile Tilapia (Oreochromis Niloticus) Skin as an Occlusive Biological Dressing in the Treatment of Burn Wounds: Phase III Randomized Controlled Trial
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.
Read the detailed description
This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.
The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. Inclusion criteria were: age ≥ 18 and ≤60 years; the presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA) and with indication for outpatient treatment; the absence of previous treatment for the current burn and an absence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others). Exclusion criteria included hypersensitivity to materials used in the study or to related compounds; history of severe adverse reactions; drug addiction, including alcohol; use of medications that could have an impact on wound healing (e.g., steroids) and pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed in sterile 0.9% saline for 5 minutes, with this process being repeated three times in a row. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. Randomization was performed using a predefined computer-generated list, with 57 patients being allocated in the test group and 58 patients being allocated in the control group.
- Conditions
- Burns
- Being tested
- Nile Tilapia Fish Skin, Silver Sulfadiazine Cream 1%
- Keywords
- Burns, Nile tilapia, Xenograft, Oreochromis niloticus, Biocompatible materials, Wound healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nile Tilapia Fish SkinDevice
Also called Tilapia Skin
In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.
Silver Sulfadiazine Cream 1%Drug
Also called Silver Sulfadiazine
Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.
| Study group | Role | What they receive |
|---|---|---|
| Silver Sulfadiazine Cream 1% | Active comparator | In the control group, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of Silver Sulfadiazine Cream 1% was applied and covered with gauze and bandage. The dressing changes occurred every 48 hours. The patients were evaluated every 48 hours for the study parameters. Receives: Drug: Silver Sulfadiazine Cream 1% |
| Nile Tilapia Fish Skin | Experimental | In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed thrice in sterile 0.9% saline for 5 minutes, in order to remove glycerol. Regarding application in the study patients, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, Nile Tilapia Fish Skin was applied and covered with gauze and bandage. Throughout the treatment, dressings with Nile Tilapia Fish Skin were only changed if the biomaterial was not properly adhered to the wound bed. The patients were evaluated every 48 hours for the study parameters. Receives: Device: Nile Tilapia Fish Skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days for complete reepithelialization of the burn wound
Number of days until complete reepithelialization of the burn wound, considering application of the first dressing as day zero. Complete reepithelialization was defined as a ≥95% reepithelialization calculated via clinical judgment from the consultant
Measured: Day 11
Number of dressings performed
In the control group, a dressing change was defined as the act of cleaning the wound and reapplying the Silver Sulfadiazine Cream 1%, which was performed every 48 hours. In the test group, a dressing change was defined as the act of replacing the Nile Tilapia Fish Skin which did not adhere properly and/or replacing gauze and bandage that is full of exudate.
Measured: Day 11
Amount of anesthetics used throughout the treatment
In order to audit analgesic intake, apart from the medication prescription (dipyrone and/or tramadol), the patients received a daily record card. They were asked to take the medication only if they felt pain, always respecting instructions in the prescription, and to register the amount of medication taken and the date on the card. Upon returning for medical evaluation, the remaining medication was checked and compared to the daily record card.
Measured: Day 11
Treatment cost per patient
Consumption of materials of the burn treatment center was controlled by the completion of a specific form, an activity performed at the end of each patient visit by the nursing staff. The resources consumed were divided into three categories: a) products used for wound management (either Nile Tilapia Fish Skin or Silver Sulfadiazine Cream 1%); (b) hospital material required for dressing preparation (such as sterile gloves, chlorhexidine, gauze, and bandage); and c) analgesic medication required throughout treatment (dipyrone and/or tramadol). Human resources were not evaluated.
Measured: Day 11
Secondary outcomes (4)
Pain intensity evaluation via Visual Analogue Scale scores
Patients were informed that the left end of the 10 cm horizontal line (with a "0") represented "no pain" and that the right end (with a "10") represented the "most severe pain imaginable." They were asked to make a mark on the line that represented their current pain intensity, and the Visual Analogue Scale pain intensity level was scored by measurement of the distance from the mark to the "no pain" end of the line.
Measured: Day 1, 3, 5, 7, 9 and 11
Pain intensity evaluation via Electronic von Frey
In the Electronic von Frey, a rigid tip of 0.7 mm in diameter is connected to an electronic system, which displays the test readings in grams (from 0.1 to 1000 g). Initially, 4 different points around the burn were chosen, each one with a distance of around 1 cm from the wound bed. The tip was applied perpendicularly to the skin surface in each of these points, with the application rate controlled entirely by the observer. The participants gave a verbal signal when the pressure was felt to be unpleasant: this measure was taken as the Mechanical Pain Threshold of that point. Subsequently, the process was repeated in a similar region of the contralateral healthy side of the body. The mean of the measures of the 4 points in each area was taken as the mean Mechanical Pain Threshold of that area. Finally, the difference between the nociception threshold of healthy skin and of the edge of the burn, expressed in grams, was determined.
Measured: Day 1, 3, 5, 7, 9 and 11
Burns Specific Pain Anxiety Scale (BSPAS) scores
The Brazilian version of the 9-item Burns Specific Pain Anxiety Scale (BSPAS) was employed. Each item in the BSPAS is scored on a 10 cm visual analogue line with two reference points given values of 0 and 10. The patient is asked how much the assertions relate to their current pain situation, with 0 corresponding to ''not at all'' and 10 corresponding to ''the worst imaginable way''. The total score is calculated by adding up the scores for all items, with a maximum of 90 points.
Measured: Day 5 and 11
Burn improvement on the day of dressing removal evaluation
Assessed via the Clinical Global Impression Scale-Improvement (CGI-I). The CGI-I is evaluated by the physician responsible and answers the following question: "Compared to the patient's condition at admission to the project, this patient's condition is: 1 - very much improved since the initiation of treatment; 2 - much improved; 3 - minimally improved; 4 - no change from baseline; 5 - minimally worse; 6 - much worse; 7 - very much worse since the initiation of treatment".
Measured: Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start3 Apr 2017
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, monocentric, open-label, controlled phase III clinical study
- Masking
- None (open label)
- Enrolment
- 115 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 de Moraes, MD, PhD, Study director, Drug Research and Development Center (NPDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202289
- Sponsor's protocol ID
- Nile Tilapia Fish Skin
- Status last verified
- Jan 2020
- First submitted
- 14 Dec 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lima-Junior EM, de Moraes Filho MO, Costa BA, Fechine FV, de Moraes MEA, Silva-Junior FR, Soares MFADN, Rocha MBS, Leontsinis CMP. Innovative treatment using tilapia skin as a xenograft for partial thickness burns after a gunpowder explosion. J Surg Case Rep. 2019 Jun 14;2019(6):rjz181. doi: 10.1093/jscr/rjz181. eCollection 2019 Jun.
PubMed 31214319Costa BA, Lima Junior EM, de Moraes Filho MO, Fechine FV, de Moraes MEA, Silva Junior FR, do Nascimento Soares MFA, Rocha MBS. Use of Tilapia Skin as a Xenograft for Pediatric Burn Treatment: A Case Report. J Burn Care Res. 2019 Aug 14;40(5):714-717. doi: 10.1093/jbcr/irz085.
PubMed 31112268Lima Junior EM, Moraes Filho MO, Forte AJ, Costa BA, Fechine FV, Alves APNN, Moraes MEA, Rocha MBS, Silva Junior FR, Soares MFADN, Bezerra AN, Martins CB, Mathor MB. Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial Partial-Thickness Wounds: A Pilot Study. J Burn Care Res. 2020 Feb 19;41(2):241-247. doi: 10.1093/jbcr/irz149.
PubMed 31504615Alves 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 29380095
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nile Tilapia (Oreochromis Niloticus) Skin as an Occlusive Biological Dressing in the Treatment of Burn Wounds: Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04202289
- Acronym / sponsor ID
- Nile Tilapia Fish Skin
- Conditions
- Burns
- Keywords
- Burns, Nile tilapia, Xenograft, Oreochromis niloticus, Biocompatible materials, Wound healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do CearaUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 17 Dec 2019 (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.
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.
Detailed description
This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.
The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. Inclusion criteria were: age ≥ 18 and ≤60 years; the presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA) and with indication for outpatient treatment; the absence of previous treatment for the current burn and an absence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others). Exclusion criteria included hypersensitivity to materials used in the study or to related compounds; history of severe adverse reactions; drug addiction, including alcohol; use of medications that could have an impact on wound healing (e.g., steroids) and pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed in sterile 0.9% saline for 5 minutes, with this process being repeated three times in a row. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. Randomization was performed using a predefined computer-generated list, with 57 patients being allocated in the test group and 58 patients being allocated in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, monocentric, open-label, controlled phase III clinical study
| Arm | Type | Receives |
|---|---|---|
| Silver Sulfadiazine Cream 1% | Active comparator | Drug: Silver Sulfadiazine Cream 1%In the control group, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of Silver Sulfadiazine Cream 1% was applied and covered with gauze and bandage. The dressing changes occurred every 48 hours. The patients were evaluated every 48 hours for the study parameters. |
| Nile Tilapia Fish Skin | Experimental | Device: Nile Tilapia Fish SkinIn the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed thrice in sterile 0.9% saline for 5 minutes, in order to remove glycerol. Regarding application in the study patients, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, Nile Tilapia Fish Skin was applied and covered with gauze and bandage. Throughout the treatment, dressings with Nile Tilapia Fish Skin were only changed if the biomaterial was not properly adhered to the wound bed. The patients were evaluated every 48 hours for the study parameters. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 and ≤60 years.
- Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
- Patient with indication for outpatient treatment.
Key exclusion criteria (6 listed)
- Previous treatment for the current burn.
- Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
- Hypersensitivity to materials used in the study or to related compounds.
- History of severe adverse reactions; drug addiction, including alcohol.
- Use of medications that could have an impact on wound healing (e.g., steroids).
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 |
|---|---|---|
| Nile Tilapia Fish SkinAlso: Tilapia SkinIn the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal. | Device | Nile Tilapia Fish Skin |
| Silver Sulfadiazine Cream 1%Also: Silver SulfadiazineTopical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns. | Drug | Silver Sulfadiazine Cream 1% |
Primary outcome
Number of days for complete reepithelialization of the burn wound
Time frame: Day 11
Number of days until complete reepithelialization of the burn wound, considering application of the first dressing as day zero. Complete reepithelialization was defined as a ≥95% reepithelialization calculated via clinical judgment from the consultant
Number of dressings performed
Time frame: Day 11
In the control group, a dressing change was defined as the act of cleaning the wound and reapplying the Silver Sulfadiazine Cream 1%, which was performed every 48 hours. In the test group, a dressing change was defined as the act of replacing the Nile Tilapia Fish Skin which did not adhere properly and/or replacing gauze and bandage that is full of exudate.
Amount of anesthetics used throughout the treatment
Time frame: Day 11
In order to audit analgesic intake, apart from the medication prescription (dipyrone and/or tramadol), the patients received a daily record card. They were asked to take the medication only if they felt pain, always respecting instructions in the prescription, and to register the amount of medication taken and the date on the card. Upon returning for medical evaluation, the remaining medication was checked and compared to the daily record card.
Treatment cost per patient
Time frame: Day 11
Consumption of materials of the burn treatment center was controlled by the completion of a specific form, an activity performed at the end of each patient visit by the nursing staff. The resources consumed were divided into three categories: a) products used for wound management (either Nile Tilapia Fish Skin or Silver Sulfadiazine Cream 1%); (b) hospital material required for dressing preparation (such as sterile gloves, chlorhexidine, gauze, and bandage); and c) analgesic medication required throughout treatment (dipyrone and/or tramadol). Human resources were not evaluated.
4 secondary outcomes
Pain intensity evaluation via Visual Analogue Scale scores
Time frame: Day 1, 3, 5, 7, 9 and 11
Pain intensity evaluation via Electronic von Frey
Time frame: Day 1, 3, 5, 7, 9 and 11
Burns Specific Pain Anxiety Scale (BSPAS) scores
Time frame: Day 5 and 11
Burn improvement on the day of dressing removal evaluation
Time frame: Day 11
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 29 Jan 2020.
- Background: PubMed 31214319Lima-Junior EM, de Moraes Filho MO, Costa BA, Fechine FV, de Moraes MEA, Silva-Junior FR, Soares MFADN, Rocha MBS, Leontsinis CMP. Innovative treatment using tilapia skin as a xenograft for partial thickness burns after a gunpowder explosion. J Surg Case Rep. 2019 Jun 14;2019(6):rjz181. doi: 10.1093/jscr/rjz181. eCollection 2019 Jun.
- Background: PubMed 31112268Costa BA, Lima Junior EM, de Moraes Filho MO, Fechine FV, de Moraes MEA, Silva Junior FR, do Nascimento Soares MFA, Rocha MBS. Use of Tilapia Skin as a Xenograft for Pediatric Burn Treatment: A Case Report. J Burn Care Res. 2019 Aug 14;40(5):714-717. doi: 10.1093/jbcr/irz085.
- Background: PubMed 31504615Lima Junior EM, Moraes Filho MO, Forte AJ, Costa BA, Fechine FV, Alves APNN, Moraes MEA, Rocha MBS, Silva Junior FR, Soares MFADN, Bezerra AN, Martins CB, Mathor MB. Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial Partial-Thickness Wounds: A Pilot Study. J Burn Care Res. 2020 Feb 19;41(2):241-247. doi: 10.1093/jbcr/irz149.
- 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.
- Register on ClinicalTrials.gov of the Phase II Randomized Controlled Trial evaluating the use of Tilapia Skin in the treatment of burn wounds.Link 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 de Moraes, MD, PhD study director
Drug Research and Development Center (NPDM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nile Tilapia Fish Skin and Silver Sulfadiazine Cream 1% in people with Burns, run by Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara at 2 sites in Brazil.
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 6 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 reepithelialization of the burn wound (time frame: Day 11). The study lists 4 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 NCT04202289, which also lists 4 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 29 Jan 2020.