Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns

December 5, 2019 updated by: University of Colorado, Denver

A Comparison of Mepitel Ag vs Antibiotic Ointment When Used With the Soft Cast Technique for the Treatment of Pediatric Hand and Foot Burns, a Prospective Study

The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated Adaptic gauze when used with the soft cast technique to assess overall time to healing, yeast infection rate and parents perception of pain level at time of dressing change on a scale of 1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique improves wound healing in pediatric partial to deep partial thickness hand and foot burns by decreasing the length of healing time, decreasing the risk of yeast infection, and decreasing pain associated with dressing changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is currently no gold standard dressing when it comes to treating hand or foot burns, specifically in the pediatric population. Our institution currently utilizes the soft cast technique (SCT) on all of our hand and foot burns. The SCT uses triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban. This dressing is applied one to two times during the first 2 weeks post injury. The underlying dressing is changed to nystatin impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban for the remainder of treatment time or until surgery is indicated for debridement and grafting of wounds. The soft cast technique provides optimal positioning of the wounded hand or foot, allows for a moist wound environment, and offers protection of the injured extremity as the wound heals. The literature reveals that early surgical intervention performed in the first 7 to 10 days post injury has been shown to help achieve maximal function while decreasing the risk of hypertrophic scar formation.

A review of the current literature demonstrates silver sulfadiazine (SSD) to be the most frequently used dressing for burn wound treatment in many clinics nationwide. The use of SSD is associated with once to twice daily painful dressing changes and wound exposure that "may lead to disruption of newly formed epithelium, wound colonization, subsequent wound infection and deepening of the burn". One major benefit of the SCT is the reduction in required dressing changes, as the soft cast can stay in place for 7-10 days while maintaining optimal hand or foot positioning. This eliminates the need for painful dressing changes. Occasionally in our clinic, we have observed yeast infections under the soft cast when patients require serial casting. Other complications include occasional drying out of the adaptic gauze, which leads to painful dressing removal and interruption of the newly epithelialized wound bed. Mepitel Ag, a new soft silicone dressing produced by Molnlycke Health Care, combines Safetac technology with a silver compound to provide a broad spectrum of antimicrobial coverage, lasting up to 8 days, while minimizing damage to the new epithelium and creating a moist wound environment. The safetac technology "protects the wound and the skin. It prevents an outer dressing from sticking to the wound, therefore minimizes trauma and pain". The highly pliable nature and antimicrobial properties of the dressing make it an ideal alternative to TAO and SSD for the treatment of pediatric partial to deep partial thickness hand and foot burns.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children's Hospital Colorado burn patients
  • Age 31 days to 18 years
  • Newly diagnosed partial to deep partial or full thickness hand or foot burns, including bilateral or unilateral injury

Exclusion Criteria:

  • silver allergy
  • silicone allergy
  • electrical burn
  • chemical burn
  • past medical history of immunodeficiency disorders such as diabetes mellitus
  • h/o AIDs or HIV,
  • h/o pregnant women
  • prisoners
  • decisionally challenged

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control- triple antibiotic ointment
triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban
Device: triple antibiotic ointment dressing
used for control group under soft cast
Experimental: Variable- mepitel Ag
mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban
Device: Mepitel Ag
used for variable/experimental group under soft cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wound Appearance From Initial Injury Until Wound Healed
Time Frame: Up to 21 days
Burn will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) after application of Mepitel Ag or triple antibiotic ointment impregnated Adaptic gauze to determine if the burn healed or not.
Up to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pain Level
Time Frame: Up to 21 days from date of surgery
Subject will be evaluated at first post-operative follow up visit ranging from date of surgery up to 21 days (End of Study) for level of pain at time of dressing change based on FLACC scale and calculated per Nurse and parent perceived level of patient pain. "The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2."
Up to 21 days from date of surgery
Presence of Yeast Infection in Burn Wound
Time Frame: Up to 21 days
Subject will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) for clinically observed evidence of yeast infection from visible wound inspection at time of dressing change, i.e.: foul yeast odor, red erythematous rash.
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Steven Moulton, M.D., University of Colorad, Childrens Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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