Back to results

Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

Primary Purpose

Skin Burn Degree Second

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Keramatrix

Mepilex

About this trial

This is an interventional treatment trial for Skin Burn Degree Second focused on measuring Burn, Second-degree

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician

Exclusion Criteria:

Patient older than 18
Causes other than flame or scald injuries (ie.chemical or frostbite)
Wounds noted to be contaminated or infected
Patients who have received previous treatment efforts (topical dressings or previous wound debridement)
Pregnancy lactation
Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment
known allergy to sheep's wool

Sites / Locations

Shriners Hospitals for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Keramatrix

Mepilex

Arm Description

Keramatrix

Mepilex

Outcomes

Primary Outcome Measures

Wound Healing

Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds.

Secondary Outcome Measures

Infection rates

Subjects will be monitored for unusual occurences, including signs and symptoms of infection.

Scarring

Scarring will be evaluated using the Vancouver Clinical Scar Scale. Assessments of graft pigmentation, vascularity, pliability and height will be performed at follow-up visits.

Pain

Pain will be assessed using pain scales according to age.

Full Information

NCT ID

NCT01790763

First Posted

November 13, 2012

Last Updated

May 12, 2015

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

Keraplast Technologies, LLC, Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT01790763

Brief Title

Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

Official Title

Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Due to lack of funding from the sponsor this study is being withdrawn.

Study Start Date

April 2015 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

Keraplast Technologies, LLC, Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.

Detailed Description

Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.

6. Conditions and Keywords

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

Skin Burn Degree Second

Keywords

Burn, Second-degree

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Keramatrix

Arm Type

Active Comparator

Arm Description

Keramatrix

Arm Title

Mepilex

Arm Type

Active Comparator

Arm Description

Mepilex

Intervention Type

Device

Intervention Name(s)

Keramatrix

Intervention Description

Dressing for second degree burn

Intervention Type

Device

Intervention Name(s)

Mepilex

Intervention Description

Dressing for second degree wound

Primary Outcome Measure Information:

Title

Wound Healing

Description

Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds.

Time Frame

Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals

Secondary Outcome Measure Information:

Title

Infection rates

Description

Subjects will be monitored for unusual occurences, including signs and symptoms of infection.

Time Frame

Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals

Title

Scarring

Description

Scarring will be evaluated using the Vancouver Clinical Scar Scale. Assessments of graft pigmentation, vascularity, pliability and height will be performed at follow-up visits.

Time Frame

52 weeks up to 78 weeks

Title

Pain

Description

Pain will be assessed using pain scales according to age.

Time Frame

duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician Exclusion Criteria: Patient older than 18 Causes other than flame or scald injuries (ie.chemical or frostbite) Wounds noted to be contaminated or infected Patients who have received previous treatment efforts (topical dressings or previous wound debridement) Pregnancy lactation Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment known allergy to sheep's wool

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Jimenez, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospitals for Children

City

Galveston

State/Province

Texas

ZIP/Postal Code

77551

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

We'll reach out to this number within 24 hrs