Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

Burn, Partial Thickness Clinical Trial

Official title:

Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02673229
• Other study ID #: 13663
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: University of Kansas Medical Center
• Contact: Jessica Reynolds, BSN
• Phone: 913-588-0044
• Email: jreynolds11[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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).

2. Have one or more acute burns which:

1. are thermal, chemical or electrical in etiology

2. in aggregate cover <10% total body surface area (TBSA)

3. are each equal to or less than 72 hrs old

4. are each no more than deep partial thickness (2nd degree)

5. are not visibly infected

3. Able to take in oral fluids.

4. Able to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply.

5. Willing to make all required study visits.

Exclusion Criteria:

1. Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).

2. Embedded foreign bodies in the burn wound which cannot be immediately removed.

3. The burned tissue includes or is within 1 cm of the eye or genitalia.

4. Severe perioral burns.

5. Airway involvement or aspiration of hot liquids.

6. Suspicion of physical abuse.

7. Burn wound requires a skin graft.

8. Outpatient management of the burn wound is not appropriate.

9. Participation in another investigational clinical study within thirty (30) days of the Screening Visit.

10. 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.

11. Test articles are cost-prohibitive for subjects

Related Conditions & MeSH terms

• Burn, Partial Thickness
• Burns

Intervention

Drug:
• Collagenase Santyl
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
• Bacitracin
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Healing		Up To 90 Days After Treatment
Other	Incidence of Burn Wound Infection		Up to 90 Days After Treatment
Primary	Proportion Healed	Outcome will be reported as percent of wound epithelialization.	21 Days After Treatment
Secondary	Scar Appearance using the Vancouver Scar Scale	Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation.	90 Days After Treatment

External Links

•   Initial study registration by study agent manufacturer before the study was modified and taken over by a new sponsor