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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681757
• Other study ID #: 15-1828
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 29, 2017

Study information

• Verified date: December 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• triple antibiotic ointment dressing
used for control group under soft cast
• Mepitel Ag
used for variable/experimental group under soft cast

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Barret JP, Herndon DN. Plantar burns in children: epidemiology and sequelae. Ann Plast Surg. 2004 Nov;53(5):462-4. — View Citation

Briggs 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. — View Citation

Brown 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. — View Citation

Bugmann 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. — View Citation

Choi M, Armstrong MB, Panthaki ZJ. Pediatric hand burns: thermal, electrical, chemical. J Craniofac Surg. 2009 Jul;20(4):1045-8. Review. — View Citation

Duteille F, Jeffery SL. A phase II prospective, non-comparative assessment of a new silver sodium carboxymethylcellulose (AQUACEL(®) 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. — View Citation

Feldmann 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. Review. — View Citation

Gee 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. — View Citation

Johnson 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. Erratum in: Phys Ther 1995 Jul;75(7):640. — View Citation

Meuleneire 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. — View Citation

Toussaint 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. — View Citation

White R, Morris C. Mepitel: a non-adherent wound dressing with Safetac technology. Br J Nurs. 2009 Jan 8-21;18(1):58-64. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 21 days
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."	Up to 21 days from date of surgery
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.	Up to 21 days