Burn, Partial ThicknessPhase 4NCT02673229
Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns
A Phase 4 study testing Collagenase Santyl and Bacitracin in people with Burn, Partial Thickness, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2013to 30 Mar 2020
- Phase
- Phase 4
- 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 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 Institutional Review Board (IRB).
- Have one or more acute burns which:
- are thermal, chemical or electrical in etiology
- in aggregate cover <10% total body surface area (TBSA)
- are each equal to or less than 72 hrs old
- are each no more than deep partial thickness (2nd degree)
Show all 10Show fewer
- 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.
- The Investigator may declare any subject ineligible for a valid medical reason. 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.
- Test articles are cost-prohibitive for subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting scar.
Read the detailed description
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 at 60 \& 180 days, up to 6 months. At these visits, the appearance of the scar will be evaluated.
This study was originally funded by Smith and Nephew, but Smith and Nephew is no longer providing support for the study.
- Conditions
- Burn, Partial Thickness
- Being tested
- Collagenase Santyl, Bacitracin
- Keywords
- Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase SantylDrug
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
BacitracinDrug
Also called Bacitracin Zinc Ointment
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Santyl | Active comparator | Applied topically (2 mm thickness once daily) Receives: Drug: Collagenase Santyl |
| Bacitracin | Sham comparator | Applied topically (2 mm thickness) once daily Receives: Drug: Bacitracin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound healing
Measured: 21 Days After Treatment
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound epithelialization
Measured: 14 days after treatment
Secondary outcomes (1)
Vancouver Scar Scale
Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. VSS is derived by adding the score for each variable. Details of VSS is below.
The Vancouver Scar Scale
Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Range of Score: 0-2 with 0 = best outcome, 2 = worst outcome
Vascularity (0-3) Normal. 0 Pink 1 Red 2 Purple. 3 Range: 0-3 with 0 = best outcome, 3 = worst outcome
Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Range of Score: 0-5, with 0 = best outcome, 5 = worst outcome
Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3 Range of Score 0-3, with 0 = best outcome, 3 = worst outcome
Interpretation of Total Score: 0 = best outcome, 13 = worst outcome
Measured: 90 Days After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start30 Sep 2013
- Primary completion27 Dec 2018
- Study completion30 Mar 2020
Why it stopped: slow enrollment due to cost of medication and conflict of interest enrolling uninsured patients
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 Burn, Partial ThicknessStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhaval Bhavsar, University of Kansas Medical Center
- Investigators
- Dhaval Bhavsar, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673229
- Sponsor's protocol ID
- 13663
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2016
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. 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
- NCT02673229
- Acronym / sponsor ID
- 13663
- Conditions
- Burn, Partial Thickness
- Keywords
- Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment due to cost of medication and conflict of interest enrolling uninsured patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting scar.
Detailed description
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 at 60 \& 180 days, up to 6 months. At these visits, the appearance of the scar will be evaluated.
This study was originally funded by Smith and Nephew, but Smith and Nephew is no longer providing support for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase Santyl | Active comparator | Drug: Collagenase SantylApplied topically (2 mm thickness once daily) |
| Bacitracin | Sham comparator | Drug: BacitracinApplied topically (2 mm thickness) once daily |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 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 Institutional Review Board (IRB).
- Have one or more acute burns which:
- 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.
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 SantylA sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP). | Drug | Collagenase Santyl |
| BacitracinAlso: Bacitracin Zinc OintmentOne gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams. | Drug | Bacitracin |
Primary outcome
Number of Subjects With at Least 95% Wound Healing
Time frame: 21 Days After Treatment
Outcome will be reported as number of subjects with at least 95% wound healing
Number of Subjects With at Least 95% Wound Healing
Time frame: 14 days after treatment
Outcome will be reported as number of subjects with at least 95% wound epithelialization
1 secondary outcome
Vancouver Scar Scale
Time frame: 90 Days After Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Initial study registration by study agent manufacturer before the study was modified and taken over by a new sponsorLink provided by the sponsor.
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.
Dhaval Bhavsar, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
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 University of Kansas Medical Center 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 10 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: stopped early, as of the sponsor's last update on 10 Jul 2024. 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. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). 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?
Number of Subjects With at Least 95% Wound Healing (time frame: 21 Days After Treatment). 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 10 Jul 2024.