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
Phase: NA
Conditions: Burns
Sponsor: University of Colorado, Denver

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A comparison of Mepitel Ag vs antibiotic ointment when used 
with a soft cast technique for the treatment of pediatric hand 
and foot burns, a prospective study 
 
 
 
 
 
 
Protocol #: 15-1828 
 
April 8, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax: 303-724-0990 
 
Protocol #: 15-1828 
Project Title: 
 A comparison of Mepitel Ag vs antibiotic ointment when used 
with a soft cast technique for the treatment of pediatric hand 
and foot burns, a prospective study 
Principal Investigator: Dr. Steven Moulton, MD 
Version Date: 3/30/16 
 
I. 
Hypotheses: 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 multiple dressing changes. 
II. Specific Aims: 
1) To examine the efficacy of Mepitel Ag for use in 
pediatric partial to deep partial thickness hand and 
foot burns. 
2) To evaluate Mepitel Ag to triple antibiotic ointment when 
used in combination with a soft cast technique comparing 
healing time, yeast infection rates and pain levels at time 
of dressing change. 
 
II. Background and Significance: 
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 
a soft cast technique  (SCT) on all of our hand and foot burns. The SCT 
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. Our current 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  two to three times during the first 2 weeks 
post injury. To reduce the risk of the development of yeast overgrowth,  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 OR is indicated for surgical debridement and 
grafting of wounds..  
 
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.28 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”.23, 28 One major benefit of the SCT is the reduction in 
 
COMIRB 
APPROVED 
08-Apr-2016 

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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 
frequent painful dressing changes.  
 
Occasionally, We have observed yeast infections when patients require serial 
casting and all have been treated with antibiotics. Other complications we have 
experienced include: occasional drying out of the adaptic gauze leading to a 
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. The 
safetac technology “protects the wound and the skin. It prevents an outer dressing from sticking to 
the wound, therefore minimizes trauma and pain”.15 The highly pliable nature and 
antimicrobialproperties 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. The silver compound  lasts up to 8 
days, while minimizing damage to the new epithelium and creating a moist wound environment.  
As Mepitel Ag is a relatively new product, there are currently no studies  analyzing its efficacy and 
effectiveness when compared to other burn treatment methods.  
 
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. 
 
III. Preliminary Studies/Progress Report: 
A review of current literature found studies comparing SSD to other silver type dressings, SSD to 
Mepitel, and silver type dressings to topical antibiotic ointments. Search results failed to return 
articles on the soft cast technique for the treatment of burn wounds or the use or efficacy of Mepitel 
Ag. According to the literature, many silver containing products including SSD, Acticoat (silver 
rayon mesh), and Aquacel Ag (hydrofibre with silver ion) are indicated for partial to full thickness 
wounds, suggesting silvers ability to penetrate deeper burn injuries to promote wound healing.1 
Many studies found the silver type dressings to be associated with shorter healing time when 
compared to SSD and antibiotic impregnated gauze.  
 
One important component of a burn dressing is “the creation of a moist wound-healing 
environment, the prevention of crust formation, and the physical protection of the wound against 
mechanical disturbances”.28 In one review, antibiotic ointment impregnated gauze demonstrated 
adherence to the wound bed, causing damage to newly epithelialized cells during the dressing 
change.28 In addition, Bacitracin, a component of TAO has been linked to promoting yeast 
colonization on healed wounds.7 Another study found yeast infections rates to be higher among 
children in the 1-16 year old age range, contributing this finding to “a higher sensitivity for Candida 
infections during childhood”.20  
 
Burn dressing changes have been reported as being some of the most traumatic and painful 
procedures for children.10, 23 In addition, daily dressing changes are rather time consuming and 
costly.28 When determining acute burn wound care, it is important to utilize dressings that optimize 
wound healing while decreasing dressing frequency and subsequent patient pain. Mepitel, a grid 
like soft silicone coated nylon dressing that adheres only to intact skin, was found to demonstrate 
shorter wound healing time, less eschar formation, decreased pain, and lower cost when 
compared to SSD in one clinical trial.28,5 According to a study by Briggs et al,“silicone –based non-
adherent dressings are especially beneficial in reducing pain during dressing changes in children.”3 

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This is due to the fact that “soft silicone dressing have been shown to  prevent trauma to the 
wound bed and periwound skin and have been described as ‘atraumatic’”.14 Other benefits of soft 
silicone dressings include the ability to conform to anatomical contours, a reduction in scar 
development, and reduced overall cost secondary to improved wound healing and need for less 
frequent dressing changes.14  
 
Mepitel Ag, a hybrid type soft silicone dressing impregnated with a silver compound was recently 
approved for use in partial thickness burns and partial and full thickness grafts.15 This combination 
of soft silicone and silver provides a relatively pain free dressing with broad spectrum antibiotic 
coverage. The aim of this study is to demonstrate that Mepitel Ag in combination with a soft cast 
technique is a superior alternative to antibiotic ointment impregnated gauze and soft cast for the 
treatment of pediatric hand and foot burns due to decreased healing time, decreased patient pain 
and lower yeast infection rates. 

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IV. Research Methods 
 
A. Outcome Measure(s): 
Primary outcomes utilized in this study include overall wound outcome, measured in length of 
days to re-epithelialization or need for surgical intervention, clinical assessment and wound 
progression photographs. Secondary outcomes include number of patients requiring surgical 
debridement, presence of infection based on odor, rash, deep red appearance or puritis. These 
wounds will not be cultured,  patient pain level with dressing change based on the FLACC 
(Face, Legs, Activity, Cry, Consolability) scale, parents perceived level of pain, pain level at 
home based on family reported pain and pain medication use. We will also assess cost 
effectiveness of dressings including the number of clinic visits, number of soft casts, and the 
cost and amount of dressings used over the course of treatment. 
 
B. Description of Population to be Enrolled: 
Patients to be included in this study will be all Children's Hospital Colorado burn patients 
between the ages of 31 days and 18 years with newly diagnosed partial to deep partial or full 
thickness hand or foot burns, including bilateral or unilateral injury. Each injured extremity will 
serve as a separate data point. Exclusions include age > 18 years at start of study, silver 
allergy, silicone allergy, electrical or chemical burn, past medical history of immunodeficiency 
disorders such as diabetes mellitus, AIDs, or HIV, pregnant women, prisoners children under 
the protection of the department of human services, and the decisionally challenged.  
 
C. Study Design and Research Methods 
New burn clinic patients identified with a partial to deep partial or full thickness hand or foot 
burn will be randomized into either the Mepitel Ag group or the control group on their first clinic 
visit based on burn wound severity and age using RedCap. The randomization scheme in 
RedCap will be independently created by a statistician. Parental consent and or patient assent 
will be obtained prior to initial dressing. Burn severity will be clinically determined by one 
provider and one burn nurse during initial exam based on a 10 point burn severity classification 
scale in regards to the following parameters: 1) Superficial first degree- wound appears pink or 
red, involves epidermis only, no blisters present,dry; 2) Second degree, superficial partial 
thickness- burn involves epidermis + dermis, red or bright pink in color with blisters and or 
swelling, blanches, moist appearing; 3) Second degree, majority superficial partial thickness, 
minority superficial- burn involves majority (>/= 66%) superficial partial thickness, epidermis + 
dermis, red or bright pink in color with blisters and or swelling, blanches, moist appearing, 
minority (~33% or less) superficial first degree with areas of redness but no blistering; 4) 
Second degree, majority partial thickness, minority deep partial thickness- majority of burn(>/= 
66%) epidermis + dermis, red or bright pink in color, moist, less than half of burn (~33% or less)  
is deep with pale pink-white areas, may or may not have a marbled or mosaic         
appearance; 5) Second degree, deep partial thickness- involves epidermis + dermis, pale pink 
to white in color, may have thin white moist eschar, may or may not have a marbled or mosaic 
type appearance, moist; 6) Second degree, majority deep partial thickness, minority superficial 
partial thickness- minority of burn (~33% or less)  involves epidermis + dermis, red or bright 
pink in color, moist, majority (>/= 66%) of burn is deep with pale pink-white areas having a 
marbled or mosaic appearance, may or may not have thin white moist eschar, skin buds may 
or may not be present; 7) Second degree, deep partial thickness with areas of full thickness- 
majority of burn(>/= 66%) involves epidermis + dermis, pale pink to white in color, may have 
thin white moist eschar, may or may not have a marbled or mosaic type appearance, moist, 
skin buds may or may not be present, minority of burn (~33% or less) demonstrates thin to 
thick area of eschar white, brown or black in color, may need skin graft to heal; 8) Third degree 
full thickness with minority partial thickness- majority of burn (>/= 66%) involves entire dermis + 
epidermis, thin to thick eschar that is white, brown or black in color, dry appearing, minority of 
burn (~33% or less) is pink or red and moist, with blisters and or swelling, blanches; 9) Third 
degree full thickness- involves entire dermis + epidermis, thin to thick eschar that is white, 

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brown or black in color, dry appearing; 10) Fourth degree- third degree + muscle and or bone 
involvement. The provider and burn nurse will each give the patient a number and the severity 
will be determined based on the average of the 2 numbers. Any patient given a number 2, 3 or 
4, will be placed into the “partial thickness” category, any patient given a 5, 6, or 7 will be placed 
into the “deep partial thickness” category, and lastly, any patient given an 8 or 9 will be placed 
into the “full thickness” category for burn severity.  
 
Patients will be randomized into oneof two groups, Mepitel Ag or standard TAO, using 
RedCap and based on a random clinical trial excel spread sheet balanced by burn severity. A 
statistician will provide a randomization scheme for investigators to follow. Photographs will be 
taken prior to dressing application at the initial visit and each subsequent visit. Patient wounds 
will be dressed in either Mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast 
material and coban for up to 21 days or until complete re-epithelialization of the wound occurs 
or unless surgery is indicated; the control, standard dressing of Triple Antibiotic Oinment 
impregnated adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material 
and coban for 10-14 days, or Nystatin  impregnated adaptic, kling or kerlex, cast padding, 
gypsoma plaster, soft cast material and coban for 8-21 days or until complete re-
epithelialization of the wound occurs or surgery is indicated. The SCT is applied by 
Occupational and Physical trained in casting and positioning.  The soft cast provides optimal 
positioning while eliminating friction on the burn area.  Dressing changes will occur every 3-10 
days  and will be determined by the   provider, based on burn wound severity. Upon each return 
clinic visit, the patient will have their wound severity assessed by the following scoring system: 
1=0% healed, 2= 20% healed; 3=40% healed; 4=60% healed; 5=80% healed; 6=100% healed.  
This will be established by provider and burn nurse examination of the wound. This will be recorded 
in RedCap.``````` 
 
A member of the nursing team  will also complete a  questionnaire at each follow up visit to 
indicate pain level with dressing change based on the FLACC scale, parents perceived level of 
pain during dressing change, parental reported pain level at home, use of home pain 
medications, type of home pain medication- narcotic vs non-narcotic, clinical assessment of 
yeast rash including odor, visible rash, use of fluconazole, ease of dressing application, and 
amount and type of product used in dressing change. 
 
D. Description, Risks and Justification of Procedures and Data Collection Tools: 
A photography release will be distributed and signed by parent at initial visit.  
 
A nursing questionnaire will be completed by nursing staff at each follow up appointment. 
 
Local wound care including cleansing, wound measurement and dressing change will be 
performed by burn team including nursing staff and occupational and physical therapists. 
Although punch biopsy with histological analysis is considered the ‘gold standard’ in assessing 
burn wound depth, it is invasive and time consuming.18 Clinical assessment remains the most 
frequent and rapid method. 18 Due to the time sensitive nature of the proposed trial and in order 
to avoid delaying wound care and initial dressing application, a 10 point clinical assessment 
scale has been created, as listed above for use in determining initial burn wound severity. 
Patient wound depth will be clinically determined by the average of the scores from the provider 
and the burn nurse.  
 
The wound will also be assessed by the provider and nurse on subsequent visits using the 
following scoring tool: 1=0% healed, 2= 20% healed; 3=40% healed; 4=60% healed; 5=80% 
healed; 6=100% healed.  This will be established by provider and burn nurse examination of the 
wound. This will be recorded in RedCap. 
 
 

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The overall risk for this study is minimal, with no foreseen adverse reactions. The risk of a silver 
allergy or adverse reaction to silicone is very rare. 
 
E. Potential Scientific Problems: 
Limitations to the proposed study design include varying diagnostic opinions between provider 
and burn nurse for the determination of superficial vs deep partial thickness burn wounds 
based on clinical assessment, provider or nurse bias based on dressing preference, and 
possible uneven trial groups. 
 
F. Data Analysis Plan: 
Analysis Plan: Demographic and clinical characteristics will be summarized and compared 
between the two treatment groups using chi-squared and two-sample t-tests for categorical 
and continuous data, respectively. For analysis of the primary outcome, time to wound healing, 
we will use Kaplan-Meier  curves, the log-rank test and a Cox proportional hazards model to 
determine the difference in days to re-epithelialization between the TAO and Mepitel Ag soft 
cast methods. Patients that require surgical intervention will be censored at the time of surgery. 
Logistic regression will be used to analyze the secondary outcomes, need for surgical 
debridement and occurrence of yeast infection. Pain level outcomes and pain medication use 
will be compared using two-sample t-tests and chi- squared tests. Cost effectiveness outcomes 
will also be analyzed. 
 
1. Sample size: A statistical power analysis was performed to estimate power, based on 
results reported in A Soft casting Technique to Manage Pediatric Hand Burns: Less Pain, 
Greater Gain.22 Considering the simplest between group comparison and assuming a 
standard deviation of 0.3, alpha of 0.05 and 50 subjects per group there is over 90% power to 
detect a difference of 2 days between the treatment groups. Thus, we expect that our 
proposed sample size of 100 burns will be adequate for the main objective of this study. 
 
 
G. Summarize Knowledge to be Gained: 
To demonstrate that Mepitel Ag in combination with a 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. 
 
H. References: 
1. Abu-Sittah G, El Khatib A, Dibo S. Thermal Injury to the Hand: Review of the Literature. 
Annals of Burns and Fire Disaster 2011; 24(4): 175-183. 
2. Barret J, Herndon D. Plantar Burns in Children: Epidemiology and Sequelae. Annals of 
Plastic Surgery 2004; 53(5): 462-464. DOI 10.1097/01.sap.0000136973.62109.cf 
3. Briggs S, Taylor A, Lansdown A.Clinical Perspective on silicone dressings and wound 
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http://dx.doi.org/10.12968/jowc.2008.17.8.30801. 
4. Brown M, Dalziel S, Herd E, Johnson K, Wong She R, Shepherd M. A randomized 
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Journal of Burn Care and Research 2015; 1-8. DOI: 10.1097/BCR.0000000000000273 
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sodium carboxymethylcellulose (Aquacel Ag BURN) glove in the management of partial 
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17. Mitura K, Oslowska J, Mitura A. A change of traditional method of treatment of partial 
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