Clinical trial NCT02681757: Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: pediatric hand burn
pediatric foot burn
mepitel Ag
soft cast technique for burn wound heaing
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 96
Sex: ALL
Minimum age (years): 31
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Wound Appearance From Initial Injury Until Wound Healed
timeFrame: Up to 21 days
Secondary outcomes:
measure: Evaluation of Pain Level
timeFrame: Up to 21 days from date of surgery
measure: Presence of Yeast Infection in Burn Wound
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorad, Childrens Hospital Colorado
name: Steven Moulton, M.D.
role: PRINCIPAL_INVESTIGATOR
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