BurnsNCT02681757
Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns
A study testing triple antibiotic ointment dressing and Mepitel Ag in people with Burns, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 days to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- triple antibiotic ointment dressing and Mepitel Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- silver allergy
- silicone allergy
- electrical burn
- chemical burn
- past medical history of immunodeficiency disorders such as diabetes mellitus
- h/o AIDs or HIV,
Show all 9Show fewer
- h/o pregnant women
- prisoners
- decisionally challenged
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- Burns
- Being tested
- triple antibiotic ointment dressing, Mepitel Ag
- Keywords
- pediatric hand burn, pediatric foot burn, mepitel Ag, soft cast technique for burn wound heaing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple antibiotic ointment dressingDevice
used for control group under soft cast
Mepitel AgDevice
used for variable/experimental group under soft cast
| Study group | Role | What they receive |
|---|---|---|
| Control- triple antibiotic ointment | Active comparator | triple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Receives: Device: triple antibiotic ointment dressing |
| Variable- mepitel Ag | Experimental | mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban Receives: Device: Mepitel Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 21 days
Secondary outcomes (2)
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."
Measured: Up to 21 days from date of surgery
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.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startSep 2016
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Moulton, M.D., Principal investigator, University of Colorad, Childrens Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681757
- Sponsor's protocol ID
- 15-1828
- Status last verified
- Dec 2019
- First submitted
- 10 Feb 2016
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abu-Sittah GS, El Khatib AM, Dibo SA. Thermal injury to the hand: review of the literature. Ann Burns Fire Disasters. 2011 Dec 31;24(4):175-85.
PubMed 22639560Barret JP, Herndon DN. Plantar burns in children: epidemiology and sequelae. Ann Plast Surg. 2004 Nov;53(5):462-4. doi: 10.1097/01.sap.0000136973.62109.cf.
PubMed 15502462Briggs SL, Taylor A, Lansdown AB. Clinical perspective on silicone dressings and wound management. J Wound Care. 2008 Aug;17(8):364-5; author reply 365-6. doi: 10.12968/jowc.2008.17.8.30801. No abstract available.
PubMed 18754199Brown M, Dalziel SR, Herd E, Johnson K, Wong She R, Shepherd M. A Randomized Controlled Study of Silver-Based Burns Dressing in a Pediatric Emergency Department. J Burn Care Res. 2016 Jul-Aug;37(4):e340-7. doi: 10.1097/BCR.0000000000000273.
PubMed 26171678Bugmann 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.
PubMed 9882058Choi M, Armstrong MB, Panthaki ZJ. Pediatric hand burns: thermal, electrical, chemical. J Craniofac Surg. 2009 Jul;20(4):1045-8. doi: 10.1097/scs.0b013e3181abb25f.
PubMed 19634213Duteille F, Jeffery SL. A phase II prospective, non-comparative assessment of a new silver sodium carboxymethylcellulose (AQUACEL((R)) Ag BURN) glove in the management of partial thickness hand burns. Burns. 2012 Nov;38(7):1041-50. doi: 10.1016/j.burns.2012.05.001. Epub 2012 Jun 5.
PubMed 22677163Feldmann ME, Evans J, O SJ. Early management of the burned pediatric hand. J Craniofac Surg. 2008 Jul;19(4):942-50. doi: 10.1097/SCS.0b013e318175f38d.
PubMed 18650716Gee Kee E, Kimble RM, Cuttle L, Stockton K. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial. Trials. 2013 Nov 25;14:403. doi: 10.1186/1745-6215-14-403.
PubMed 24274190Johnson J, Silverberg R. Serial casting of the lower extremity to correct contractures during the acute phase of burn care. Phys Ther. 1995 Apr;75(4):262-6. doi: 10.1093/ptj/75.4.262.
PubMed 7899484Meuleneire F, Rucknagel H. Soft Silicone dressings made easy. Wounds International 2013.
Mitura K, Oslowska J, Mitura A. A Change of Traditional Method of Treatment of Partial Thickness Burn with Hydrofibre Dressings. Pol Przegl Chir. 2015 Feb;87(2):91-6. doi: 10.1515/pjs-2015-0025.
PubMed 26146101White R, Morris C. Mepitel: a non-adherent wound dressing with Safetac technology. Br J Nurs. 2009 Jan 8-21;18(1):58-64. doi: 10.12968/bjon.2009.18.1.93582.
PubMed 19127235Toussaint J, Chung WT, Osman N, McClain SA, Raut V, Singer AJ. Topical antibiotic ointment versus silver-containing foam dressing for second-degree burns in swine. Acad Emerg Med. 2015 Aug;22(8):927-33. doi: 10.1111/acem.12723. Epub 2015 Jul 22.
PubMed 26202791
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02681757
- Acronym / sponsor ID
- 15-1828
- Conditions
- Burns
- Keywords
- pediatric hand burn, pediatric foot burn, mepitel Ag, soft cast technique for burn wound heaing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control- triple antibiotic ointment | Active comparator | Device: triple antibiotic ointment dressingtriple antibiotic ointment (TAO) impregnated Adaptic gauze, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban |
| Variable- mepitel Ag | Experimental | Device: Mepitel Agmepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban |
Who may qualify
- Ages
- 31 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- silver allergy
- silicone allergy
- electrical burn
- chemical burn
- past medical history of immunodeficiency disorders such as diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triple antibiotic ointment dressingused for control group under soft cast | Device | Control- triple antibiotic ointment |
| Mepitel Agused for variable/experimental group under soft cast | Device | Variable- mepitel Ag |
Primary outcome
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.
2 secondary outcomes
Evaluation of Pain Level
Time frame: Up to 21 days from date of surgery
Presence of Yeast Infection in Burn Wound
Time frame: Up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22639560Abu-Sittah GS, El Khatib AM, Dibo SA. Thermal injury to the hand: review of the literature. Ann Burns Fire Disasters. 2011 Dec 31;24(4):175-85.
- Background: PubMed 15502462Barret JP, Herndon DN. Plantar burns in children: epidemiology and sequelae. Ann Plast Surg. 2004 Nov;53(5):462-4. doi: 10.1097/01.sap.0000136973.62109.cf.
- Background: PubMed 18754199Briggs SL, Taylor A, Lansdown AB. Clinical perspective on silicone dressings and wound management. J Wound Care. 2008 Aug;17(8):364-5; author reply 365-6. doi: 10.12968/jowc.2008.17.8.30801. No abstract available.
- Background: PubMed 26171678Brown M, Dalziel SR, Herd E, Johnson K, Wong She R, Shepherd M. A Randomized Controlled Study of Silver-Based Burns Dressing in a Pediatric Emergency Department. J Burn Care Res. 2016 Jul-Aug;37(4):e340-7. doi: 10.1097/BCR.0000000000000273.
- Background: PubMed 9882058Bugmann 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.
- Background: PubMed 19634213Choi M, Armstrong MB, Panthaki ZJ. Pediatric hand burns: thermal, electrical, chemical. J Craniofac Surg. 2009 Jul;20(4):1045-8. doi: 10.1097/scs.0b013e3181abb25f.
- Background: PubMed 22677163Duteille F, Jeffery SL. A phase II prospective, non-comparative assessment of a new silver sodium carboxymethylcellulose (AQUACEL((R)) Ag BURN) glove in the management of partial thickness hand burns. Burns. 2012 Nov;38(7):1041-50. doi: 10.1016/j.burns.2012.05.001. Epub 2012 Jun 5.
- Background: PubMed 18650716Feldmann ME, Evans J, O SJ. Early management of the burned pediatric hand. J Craniofac Surg. 2008 Jul;19(4):942-50. doi: 10.1097/SCS.0b013e318175f38d.
- Background: PubMed 24274190Gee Kee E, Kimble RM, Cuttle L, Stockton K. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial. Trials. 2013 Nov 25;14:403. doi: 10.1186/1745-6215-14-403.
- Background: PubMed 7899484Johnson J, Silverberg R. Serial casting of the lower extremity to correct contractures during the acute phase of burn care. Phys Ther. 1995 Apr;75(4):262-6. doi: 10.1093/ptj/75.4.262.
- BackgroundMeuleneire F, Rucknagel H. Soft Silicone dressings made easy. Wounds International 2013.
- Background: PubMed 26146101Mitura K, Oslowska J, Mitura A. A Change of Traditional Method of Treatment of Partial Thickness Burn with Hydrofibre Dressings. Pol Przegl Chir. 2015 Feb;87(2):91-6. doi: 10.1515/pjs-2015-0025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Moulton, M.D. principal investigator
University of Colorad, Childrens Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple antibiotic ointment dressing and Mepitel Ag in people with Burns, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wound Appearance From Initial Injury Until Wound Healed (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681757, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.