Jellyfish StingsNCT02015195
Effective Treatments for Jellyfish Stings
A study testing Acetic Acid (5%), Sodium Bicarbonate Slurry (50%) and Papain Slurry (70%) in people with Jellyfish Stings, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Jellyfish Stings
- What is being tested?
- Acetic Acid (5%), Sodium Bicarbonate Slurry (50%) and Papain Slurry (70%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-65 years
- Healthy volunteers
Who cannot join
- Known history of allergic reaction or anaphylaxis to prior Cnidaria sting of there envenomations
- Family history of anaphylaxis to any sting from either Cnidaria, bee, or wasp
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Palo Alto, California, 90035
About this study
Official title: Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings
The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.
Jellyfish stings are a common occurrence in many parts of the world causing significant morbidity to persons stung by jellyfish while participating in marine activities whether commercial or recreational. Much debate and confusion exist both in the medical literature and the common recommendations regarding how to treat persons stung by jellyfish. Specifically concerning what topical treatments are most efficacious at decreasing envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst, decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal recommendations and past studies have referenced numerous different topical treatments for jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits, ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old wine, salt water, cold packs, hot water, and commercial products such as Stingose and Stingaid. Conflicting data exists regarding what works and what does not for nematocysts discharge, skin erythema, and pain reaction.
Read more
The investigators would like to investigate which treatment is best out of some of the more commonly studied treatments for reducing pain and erythema.
The investigators would like to complete a research study to try to bring some reasonable evidence to the field treatment of jellyfish stings, namely, the decontamination process (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).
The questions asked are as follows:
- What topical treatments for jellyfish stings actually decrease the amount of inflammation seen on a macroscopic level on the skin of humans?
- What topical treatments for jellyfish stings actually decrease the sensation of pain in humans?
- Do topical chemical treatments cause different outcomes when exposed to the above parameters?
- Do different species of jellyfish nematocysts react differently based on the type of topical chemical treatment used? What is the variation of effects of topical treatments based on the species of jellyfish sting?
Specifically, the investigators will be stinging human subject on both arms with a segment of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%), isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will include pain and erythema.
- Conditions
- Jellyfish Stings
- Being tested
- Acetic Acid (5%), Sodium Bicarbonate Slurry (50%), Papain Slurry (70%), Ammonia (10%), Lidocaine (4%)
- Keywords
- Jellyfish stings, Treatment, Humans, Topical Treatments, Pain, Erythema
- Medical subject headings
- Pain, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic Acid (5%)Other
Also called Vinegar
Sodium Bicarbonate Slurry (50%)Other
Papain Slurry (70%)Other
Also called Adolfo's Meat tenderizer
Ammonia (10%)Other
Also called Household ammonia
Lidocaine (4%)Drug
Also called Liquid Lidocaine
Isopropyl Alcohol (70%)Other
Also called Rubbing alcohol
Hot Tap Water (40 degrees Celsius)Other
Also called Hot Water
No treatmentOther
Also called Nothing is given topically to treat sting. This is the control.
| Study group | Role | What they receive |
|---|---|---|
| Acetic Acid 5% | Experimental | Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Acetic Acid (5%); Other: No treatment |
| Sodium Bicarbonate Slurry (50%) | Experimental | Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Sodium Bicarbonate Slurry (50%); Other: No treatment |
| Papain Slurry (70%) | Experimental | Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Papain Slurry (70%); Other: No treatment |
| Household ammonia (10%) | Experimental | Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Ammonia (10%); Other: No treatment |
| Lidocaine (4%) | Experimental | Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Drug: Lidocaine (4%); Other: No treatment |
| Isopropyl Alcohol (70%) | Experimental | Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Isopropyl Alcohol (70%); Other: No treatment |
| Hot Water (40 degrees Celsius) | Experimental | Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes Receives: Other: Hot Tap Water (40 degrees Celsius); Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours
Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group.
Measured: 24 hours
Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours
Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20).
Measured: 30 minutes, 1 hour, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jellyfish StingsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S Auerbach, Stanford University
- Investigators
- Paul S Auerbach, MD, Principal investigator, Division of Emergency Medicine, Stanford University Medical CenterMatthieu P DeClerck, MD, Study director, Division of Emergency Medicine, Stanford University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015195
- Sponsor's protocol ID
- JSP-001
- Status last verified
- Apr 2015
- First submitted
- 4 Dec 2013
- Last updated
- 13 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Agents in the Treatment of Chrysaora Chinensis Stings
- ClinicalTrials.gov ID
- NCT02015195
- Acronym / sponsor ID
- JSP-001
- Conditions
- Jellyfish Stings
- Keywords
- Jellyfish stings, Treatment, Humans, Topical Treatments, Pain, Erythema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 13 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.
Jellyfish stings are a common occurrence in many parts of the world causing significant morbidity to persons stung by jellyfish while participating in marine activities whether commercial or recreational. Much debate and confusion exist both in the medical literature and the common recommendations regarding how to treat persons stung by jellyfish. Specifically concerning what topical treatments are most efficacious at decreasing envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst, decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal recommendations and past studies have referenced numerous different topical treatments for jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits, ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old wine, salt water, cold packs, hot water, and commercial products such as Stingose and Stingaid. Conflicting data exists regarding what works and what does not for nematocysts discharge, skin erythema, and pain reaction.
The investigators would like to investigate which treatment is best out of some of the more commonly studied treatments for reducing pain and erythema.
The investigators would like to complete a research study to try to bring some reasonable evidence to the field treatment of jellyfish stings, namely, the decontamination process (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).
The questions asked are as follows:
- What topical treatments for jellyfish stings actually decrease the amount of inflammation seen on a macroscopic level on the skin of humans?
- What topical treatments for jellyfish stings actually decrease the sensation of pain in humans?
- Do topical chemical treatments cause different outcomes when exposed to the above parameters?
- Do different species of jellyfish nematocysts react differently based on the type of topical chemical treatment used? What is the variation of effects of topical treatments based on the species of jellyfish sting?
Specifically, the investigators will be stinging human subject on both arms with a segment of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%), isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will include pain and erythema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Acetic Acid 5% | Experimental | Other: Acetic Acid (5%), Other: No treatmentAcetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Sodium Bicarbonate Slurry (50%) | Experimental | Other: Sodium Bicarbonate Slurry (50%), Other: No treatmentSodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Papain Slurry (70%) | Experimental | Other: Papain Slurry (70%), Other: No treatmentPapain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Household ammonia (10%) | Experimental | Other: Ammonia (10%), Other: No treatmentAmmonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Lidocaine (4%) | Experimental | Drug: Lidocaine (4%), Other: No treatmentLidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Isopropyl Alcohol (70%) | Experimental | Other: Isopropyl Alcohol (70%), Other: No treatmentIsopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
| Hot Water (40 degrees Celsius) | Experimental | Other: Hot Tap Water (40 degrees Celsius), Other: No treatmentHot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-65 years
- Healthy volunteers
Key exclusion criteria (3 listed)
- Known history of allergic reaction or anaphylaxis to prior Cnidaria sting of there envenomations
- Family history of anaphylaxis to any sting from either Cnidaria, bee, or wasp
- Pregnancy
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 |
|---|---|---|
| Acetic Acid (5%)Also: Vinegar | Other | Acetic Acid 5% |
| Sodium Bicarbonate Slurry (50%) | Other | Sodium Bicarbonate Slurry (50%) |
| Papain Slurry (70%)Also: Adolfo's Meat tenderizer | Other | Papain Slurry (70%) |
| Ammonia (10%)Also: Household ammonia | Other | Household ammonia (10%) |
| Lidocaine (4%)Also: Liquid Lidocaine | Drug | Lidocaine (4%) |
| Isopropyl Alcohol (70%)Also: Rubbing alcohol | Other | Isopropyl Alcohol (70%) |
| Hot Tap Water (40 degrees Celsius)Also: Hot Water | Other | Hot Water (40 degrees Celsius) |
| No treatmentAlso: Nothing is given topically to treat sting. This is the control. | Other | Acetic Acid 5%, Hot Water (40 degrees Celsius), Household ammonia (10%), Isopropyl Alcohol (70%), Lidocaine (4%), Papain Slurry (70%), Sodium Bicarbonate Slurry (50%) |
Primary outcome
Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours
Time frame: 24 hours
Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The "mean change" for the treatment arm was then compared with the "mean change" for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group.
Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours
Time frame: 30 minutes, 1 hour, and 24 hours
Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with "0" representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a "scale" from -20 to +20 with "0" being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the "treatment arm" was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Paul S Auerbach, MD principal investigator
Division of Emergency Medicine, Stanford University Medical Center
Matthieu P DeClerck, MD study director
Division of Emergency Medicine, Stanford University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic Acid (5%), Sodium Bicarbonate Slurry (50%) and Papain Slurry (70%) in people with Jellyfish Stings, run by Stanford University at 1 site in United States.
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 2 inclusion and 3 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2015.