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

NCT02681757 | Completed Results DMC

• 1 other identifier: 15-1828
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of Pain Level

  Up to 21 days from date of surgery

• Presence of Yeast Infection in Burn Wound

  Up to 21 days

Study Arms (2)

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

Device: triple antibiotic ointment dressing

Variable- mepitel Ag

EXPERIMENTAL

mepitel Ag, kling or kerlex, cast padding, gypsoma plaster, soft cast material, and coban

Device: Mepitel Ag

Interventions

triple antibiotic ointment dressing DEVICE

used for control group under soft cast

Control- triple antibiotic ointment

Mepitel Ag DEVICE

used for variable/experimental group under soft cast

Variable- mepitel Ag

Eligibility Criteria

• Age: 31 Days - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related 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.

  PMID: 22639560 BACKGROUND

• Barret 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.

  PMID: 15502462 BACKGROUND

• 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. doi: 10.12968/jowc.2008.17.8.30801. No abstract available.

  PMID: 18754199 BACKGROUND

• 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.

  PMID: 26171678 BACKGROUND

• 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. doi: 10.1016/s0305-4179(98)00095-3.

  PMID: 9882058 BACKGROUND

• Choi 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.

  PMID: 19634213 BACKGROUND

• Duteille 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.

  PMID: 22677163 BACKGROUND

• 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.

  PMID: 18650716 BACKGROUND

• 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.

  PMID: 24274190 BACKGROUND

• 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. doi: 10.1093/ptj/75.4.262.

  PMID: 7899484 BACKGROUND

• Meuleneire F, Rucknagel H. Soft Silicone dressings made easy. Wounds International 2013.

  BACKGROUND

• 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.

  PMID: 26146101 BACKGROUND

• White 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.

  PMID: 19127235 BACKGROUND

• 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.

  PMID: 26202791 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Choi Young Mee MD
• Organization: Children's Hospital Colorado

youngmeeyoungmee@gmail.com

7207770859

Study Officials

• Steven Moulton, M.D.

  University of Colorad, Childrens Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 12, 2016
• Study Start: September 1, 2016
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)