Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02681757
Enrollment
96
Registered
2016-02-12
Start date
2016-09-30
Completion date
2017-09-29
Last updated
2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

pediatric hand burn, pediatric foot burn, mepitel Ag, soft cast technique for burn wound heaing

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.

Interventions

DEVICEtriple antibiotic ointment dressing

used for control group under soft cast

used for variable/experimental group under soft cast

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
31 Days to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Wound Appearance From Initial Injury Until Wound HealedUp to 21 daysBurn 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.

Secondary

MeasureTime frameDescription
Evaluation of Pain LevelUp to 21 days from date of surgerySubject 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.
Presence of Yeast Infection in Burn WoundUp to 21 daysSubject 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control- Triple Antibiotic Ointment
triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban triple antibiotic ointment dressing: used for control group under soft cast
47
Variable- Mepitel Ag
mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Mepitel Ag: used for variable/experimental group under soft cast
49
Total96

Baseline characteristics

CharacteristicVariable- Mepitel AgTotalControl- Triple Antibiotic Ointment
Age, Categorical
<=18 years
49 Participants96 Participants47 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous1.6 years1.8 years2.3 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
49 participants96 participants47 participants
Sex: Female, Male
Female
15 Participants35 Participants20 Participants
Sex: Female, Male
Male
34 Participants61 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 470 / 49
other
Total, other adverse events
0 / 470 / 49
serious
Total, serious adverse events
0 / 470 / 49

Outcome results

Primary

Change in Wound Appearance From Initial Injury Until Wound Healed

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.

Time frame: Up to 21 days

Population: Some participants had multiple burns. We investigated all burns.

ArmMeasureValue (COUNT_OF_UNITS)
Control- Triple Antibiotic OintmentChange in Wound Appearance From Initial Injury Until Wound Healed43 Burns
Variable- Mepitel AgChange in Wound Appearance From Initial Injury Until Wound Healed51 Burns
Secondary

Evaluation of Pain Level

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.

Time frame: Up to 21 days from date of surgery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control- Triple Antibiotic OintmentEvaluation of Pain Level16 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level41 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level031 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level52 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level20 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level61 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain LevelNot Reported2 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level72 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level32 Participants
Control- Triple Antibiotic OintmentEvaluation of Pain Level80 Participants
Variable- Mepitel AgEvaluation of Pain LevelNot Reported5 Participants
Variable- Mepitel AgEvaluation of Pain Level81 Participants
Variable- Mepitel AgEvaluation of Pain Level024 Participants
Variable- Mepitel AgEvaluation of Pain Level17 Participants
Variable- Mepitel AgEvaluation of Pain Level27 Participants
Variable- Mepitel AgEvaluation of Pain Level31 Participants
Variable- Mepitel AgEvaluation of Pain Level42 Participants
Variable- Mepitel AgEvaluation of Pain Level50 Participants
Variable- Mepitel AgEvaluation of Pain Level62 Participants
Variable- Mepitel AgEvaluation of Pain Level70 Participants
Secondary

Presence of Yeast Infection in Burn Wound

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.

Time frame: Up to 21 days

Population: The unit of observation is a single burn, not an individual patient. This outcome is number of yeast infections per burn dressing group.

ArmMeasureValue (NUMBER)
Control- Triple Antibiotic OintmentPresence of Yeast Infection in Burn Wound5 burns
Variable- Mepitel AgPresence of Yeast Infection in Burn Wound6 burns

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026