- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149808
Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patients will be recruited at the Children's Hospital of Michigan burn center or clinic by research personnel. If a patient is determined to fit inclusion criteria, parental consent will be obtained using the attached consent form by one of the research personnel. If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. Also, a translator will be used to explain the full consent form used for English speaking patients. This form will be witnessed by a person who speaks the native language fluently. Only one parent will be required to sign consent as many patients only have one parent available in the hospital with them and this study involves only treatments that are current standard of care. If the patient is ages 7-12 years, an oral assent will be completed before participation in the study. If the patient is between ages 13-17, an assent form will be explained to them and their signature required to participate in the study. If they speak another language, assent will be obtained using a translator and the same methods listed above for parental consent. If the recruitment accrues beyond 4-6 non-english speaking participants, who speak a certain language, the consent forms will be translated into this language for future participants.
Study Protocol:
Once consent is obtained, and the patient is determined to be ready for a dressing application, one half of the extremity burn will be treated with Mepilex Ag and the other half of the extremity burn will be treated with Xeroform. Both of these treatments are current standard of care for a partial thickness scald burn in pediatric patients. The patients will be followed inpatient until they are discharged and then followed weekly at burn clinic appointments, the same care all of our burn patients receive. A survey will be administered to burn staff and patient's parents when the treatments are applied, at follow-up clinic appointments, and after the wound is healed completely. We will evaluate clinician and nurse ease of use, comfort of each dressing for the child, pain and itching associated with each dressing and dressing change, healing time, appearance of the scar after it is completely healed using the Vancouver Scar Scale, and parental satisfaction and ease of use for each dressing.
Data Collection and Evaluation:
A chart review will be performed for all patients to obtain demographic data including age, name, birth date, date of injury, injury details, the initial treatment applied if a different dressing was used before the patient was ready for application of Xeroform or Mepilex Ag, and any other pertinent information regarding the burn treatment. Study personnel and an attending physician will evaluate each patient at weekly follow-up visits or inpatient if the patient is being treated in the hospital. Survey results and other data will be evaluated after 10 patients complete treatment. Photographs taken as part of every burn patient's care may be reviewed as part of the study. These are obtained by medical photography and securely stored digitally. The Vancouver Scar Scale will be used for final evaluation of the healed scar after treatment is complete.
All data obtained in paper form will be stored in a locked filing cabinet in a locked office in the Pediatric Surgery Department and data obtained in digital form will be secure in a password protected file on the electronic medical record server.
Statistics will be performed using Statistical Package for Social Sciences (IBM version 22.0) and the statistical program R (r-project.org). The statistics to be performed for continuous variables (which are most of the assessment measures) will include a dependent groups analysis (e.g. paired samples t-test or robust analogue of this test such as Yuen's method for trimmed means, comparing medians, or bootstrap methods). The statistics to be performed for dichotomous measures will be the Sign test, which assesses differences in positive and negative outcomes for each treatment group.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elika Ridelman, PhD
- Phone Number: 313-745-5841
- Email: eridelma@dmc.org
Study Contact Backup
- Name: Christina Shanti, MD
- Phone Number: 3137455881
- Email: CShanti@dmc.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients under age 17 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns to extremities.
- Burn of 1% TBSA or greater
- Within 48 hours of injury.
- Signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
Exclusion Criteria:
- Flame burns
- age over 18 years
- infection
- skin graft or donor site
- burns greater than 48 hours old.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Xeroform Control
A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag).
Approximately 50% of the wound is treated with xeroform dressing, which is the standard of care.
|
Standard of care dressing for low to medium exuding burns and wounds.
|
Experimental: Mepilex Ag Intervention
A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag).
Approximately 50% of the wound is treated with Mepilex Ag; the product being tested.
|
Dressing for low to medium exuding burns and wounds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scar Evaluation
Time Frame: burn injury healing time; up to 10 weeks
|
Vancouver Scar Scale: 0 is defined as normal in all instances
|
burn injury healing time; up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dressing Change Survey
Time Frame: during the burn injury treatment, up to 10 weeks
|
|
during the burn injury treatment, up to 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elika Ridelman, PhD, Wayne State University
Publications and helpful links
General Publications
- Bugmann P, Taylor S, Gyger D, Lironi A, Genin B, Vunda A, La Scala G, Birraux J, Le Coultre C. A silicone-coated nylon dressing reduces healing time in burned paediatric patients in comparison with standard sulfadiazine treatment: a prospective randomized trial. Burns. 1998 Nov;24(7):609-12. doi: 10.1016/s0305-4179(98)00095-3.
- Dykes PJ, Heggie R. The link between the peel force of adhesive dressings and subjective discomfort in volunteer subjects. J Wound Care. 2003 Jul;12(7):260-2. doi: 10.12968/jowc.2003.12.7.26567.
- Gotschall CS, Morrison MI, Eichelberger MR. Prospective, randomized study of the efficacy of Mepitel on children with partial-thickness scalds. J Burn Care Rehabil. 1998 Jul-Aug;19(4):279-83. doi: 10.1097/00004630-199807000-00002.
- Hollinworth H, Collier M. Nurses' views about pain and trauma at dressing changes: results of a national survey. J Wound Care. 2000 Sep;9(8):369-73. doi: 10.12968/jowc.2000.9.8.26282.
- O'Donovan DA, Mehdi SY, Eadie PA. The role of Mepitel silicone net dressings in the management of fingertip injuries in children. J Hand Surg Br. 1999 Dec;24(6):727-30. doi: 10.1054/jhsb.1999.0270.
- Platt AJ, Phipps A, Judkins K. A comparative study of silicone net dressing and paraffin gauze dressing in skin-grafted sites. Burns. 1996 Nov;22(7):543-5. doi: 10.1016/0305-4179(96)00035-6.
- Williams G, Withey S, Walker CC. Longstanding pigmentary changes in paediatric scalds dressed with a non-adherent siliconised dressing. Burns. 2001 Mar;27(2):200-2. doi: 10.1016/s0305-4179(00)00082-6.
- Winter GD (1975) Methods for the biological evaluation of dressings. In: Turner TD, Brain KR, eds. Surgical Dressings in the Hospital Environment. Surgical Dressings Research Unit, UWIST, Cardiff: 47-81
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 061019MP2E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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