Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns

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.

Study Overview

• Status: Terminated
• Conditions: Burn, Partial Thickness
• Intervention / Treatment: Drug: Collagenase Santyl; Drug: Bacitracin

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collagenase Santyl; Applied topically (2 mm thickness once daily)	Drug: Collagenase Santyl; A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
Sham Comparator: Bacitracin; Applied topically (2 mm thickness) once daily	Drug: Bacitracin; One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.; Other Names: Bacitracin Zinc Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least 95% Wound Healing	Outcome will be reported as number of subjects with at least 95% wound healing	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	14 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 Days After Treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Healing	time to heal in days	Up To 90 Days After Treatment
Number of Participants With a Burn Wound Infection	Number of participants with a burn wound infection cellulitis	Up to 90 Days After Treatment

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Dhaval Bhavsar, MD, University of Kansas Medical Center

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2013
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimated): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Burn; Scar Appearance; Santyl; Partial Thickness Burn; Second Degree Burn; Minor Burn Bacitracin
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Bacitracin
• Other Study ID Numbers: 13663