Back to results

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

Primary Purpose

Burn, Partial Thickness

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Collagenase Santyl

Bacitracin

About this trial

This is an interventional treatment trial for Burn, Partial Thickness focused on measuring Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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.

Exclusion Criteria:

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.
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

Sites / Locations

University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Collagenase Santyl

Bacitracin

Arm Description

Applied topically (2 mm thickness once daily)

Applied topically (2 mm thickness) once daily

Outcomes

Primary Outcome Measures

Proportion Healed

Outcome will be reported as percent of wound epithelialization.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02673229

First Posted

February 1, 2016

Last Updated

July 18, 2019

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02673229

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn, Partial Thickness

Keywords

Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Collagenase Santyl

Arm Type

Active Comparator

Arm Description

Applied topically (2 mm thickness once daily)

Arm Title

Bacitracin

Arm Type

Sham Comparator

Arm Description

Applied topically (2 mm thickness) once daily

Intervention Type

Drug

Intervention Name(s)

Collagenase Santyl

Intervention Description

A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).

Intervention Type

Drug

Intervention Name(s)

Bacitracin

Other Intervention Name(s)

Bacitracin Zinc Ointment

Intervention Description

One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.

Primary Outcome Measure Information:

Title

Proportion Healed

Description

Outcome will be reported as percent of wound epithelialization.

Time Frame

21 Days After Treatment

Secondary Outcome Measure Information:

Title

Scar Appearance using the Vancouver Scar Scale

Description

Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation.

Time Frame

90 Days After Treatment

Other Pre-specified Outcome Measures:

Title

Time to Healing

Time Frame

Up To 90 Days After Treatment

Title

Incidence of Burn Wound Infection

Time Frame

Up to 90 Days After Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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. Exclusion Criteria: 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Reynolds, BSN

Phone

913-588-0044

jreynolds11@kumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dhaval Bhavsar, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.gov/ct2/show/NCT01516463

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs