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

Skin Burn Degree Second Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01790763
• Other study ID #: 12-203
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 13, 2012
• Last updated: May 12, 2015
• Start date: April 2015
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Skin Burn Degree Second

Intervention

Device:
• Keramatrix
Dressing for second degree burn
• Mepilex
Dressing for second degree wound

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Keraplast Technologies, LLC, Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals	No
Secondary	Infection rates	Subjects will be monitored for unusual occurences, including signs and symptoms of infection.	Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals	No
Secondary	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.	52 weeks up to 78 weeks	No
Secondary	Pain	Pain will be assessed using pain scales according to age.	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	No