Burn, Partial ThicknessPhase 4NCT01516463
Using Santyl or Bacitracin on Second Degree Burns
A Phase 4 study testing Collagenase Santyl and Bacitracin in people with Burn, Partial Thickness, run by Healthpoint.
Trial summary
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Burn, Partial Thickness
- What is being tested?
- Collagenase Santyl and Bacitracin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 4
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. For subjects not able to provide informed consent (e.g., minors), a parent or legally authorized representative must provide consent. Assent must be provided as required by the IRB.
- Age 2 - 75 yrs, either sex, any race.
- Have one or more acute burns which:
- • are thermal, chemical or electrical in etiology
- • in aggregate cover <10% TBSA
- • are each equal to or less than 72 hrs old
Show all 11Show fewer
- • are each no more than deep partial thickness (2nd degree)
- • are not visibly infected
- Able to take in oral fluids.
- Able to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply.
- Willing to make all required study visits.
Who cannot join
- Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).
- Embedded foreign bodies in the burn wound which cannot be immediately removed.
- The burned tissue includes or is within 1 cm of the eye or genitalia.
- Severe perioral burns.
- Airway involvement or aspiration of hot liquids.
- Suspicion of physical abuse.
Show all 11Show fewer
- Burn wound requires a skin graft.
- Outpatient management of the burn wound is not appropriate.
- Participation in another investigational clinical study within thirty (30) days of the Screening Visit.
- Current or recent (< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease or evidence of other diseases based upon a review of medical history that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- The Medical Monitor and / or Investigator may declare any subject ineligible for a valid medical reason.
About this study
Official title: Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar.
The study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin.
Subjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated
- Conditions
- Burn, Partial Thickness
- Being tested
- Collagenase Santyl, Bacitracin
- Keywords
- burn, partial thickness burn, second degree burn, minor burn, scar, Santyl, Bacitracin, outpatient burn center, scar appearance, Kansas City, University of Kansas Medical Center, KUMC
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase SantylDrug
Applied topically (2 mm thickness once daily)
BacitracinBiological
Applied topically (2 mm thickness) once daily
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Santyl | Active comparator | Not described Receives: Drug: Collagenase Santyl |
| Bacitracin | Sham comparator | Not described Receives: Biological: Bacitracin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Appearance
Measured: 90 Days
Secondary outcomes (1)
Proportion healed at two weeks
Measured: 2 weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn, Partial ThicknessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointDhaval Bhavsar, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516463
- Sponsor's protocol ID
- 017-101-09-031
- Status last verified
- May 2012
- First submitted
- 19 Jan 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
- ClinicalTrials.gov ID
- NCT01516463
- Acronym / sponsor ID
- 017-101-09-031
- Conditions
- Burn, Partial Thickness
- Keywords
- burn, partial thickness burn, second degree burn, minor burn, scar, Santyl, Bacitracin, outpatient burn center
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- 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.
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar.
The study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin.
Subjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase Santyl | Active comparator | Drug: Collagenase Santyl |
| Bacitracin | Sham comparator | Biological: Bacitracin |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. For subjects not able to provide informed consent (e.g., minors), a parent or legally authorized representative must provide consent. Assent must be provided as required by the IRB.
- Age 2 - 75 yrs, either sex, any race.
- Have one or more acute burns which:
- • are thermal, chemical or electrical in etiology
- • in aggregate cover <10% TBSA
Key exclusion criteria (11 listed)
- Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).
- Embedded foreign bodies in the burn wound which cannot be immediately removed.
- The burned tissue includes or is within 1 cm of the eye or genitalia.
- Severe perioral burns.
- Airway involvement or aspiration of hot liquids.
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 |
|---|---|---|
| Collagenase SantylApplied topically (2 mm thickness once daily) | Drug | Collagenase Santyl |
| BacitracinApplied topically (2 mm thickness) once daily | Biological | Bacitracin |
Primary outcome
Scar Appearance
Time frame: 90 Days
1 secondary outcome
Proportion healed at two weeks
Time frame: 2 weeks after initiation of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
Related trials for Burn, Partial Thickness
RecruitingPhase 3
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Burns
Active, not recruitingPhase 2
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
Burns
Not yet recruiting
Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
Partial-thickness Burn, Pain
RecruitingPhase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Burns
Not yet recruiting
Silver Sulfadiazine With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Partial-Thickness Burns
Partial-Thickness Burn, Thermal Burn
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.
Herbert B Slade, MD study chair
Healthpoint
Dhaval Bhavsar, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Santyl and Bacitracin in people with Burn, Partial Thickness, run by Healthpoint.
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 11 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 May 2012. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Scar Appearance (time frame: 90 Days). 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 16 May 2012.