Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury

Second-degree Burn Clinical Trial

Official title:

Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04149808
• Other study ID #: 061019MP2E
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Mepilex Ag is also an approved treatment for these types of burns and has the potential to cause less pain with dressing changes, however is not used as frequently due to a much higher cost. Studies evaluating the treatment of partial thickness burns in pediatric patients have shown decreased cost and length of stay associated with dressings that are silver impregnated, like Mepilex Ag. However, these studies are all retrospective with a possible selection bias to patients. In addition, several studies have suggested less pain with newer foam and hydrofiber dressings. We are conducting a prospective study using patients with partial thickness burns of their extremities, applying Xeroform on half of the burn, and Mepilex Ag on the other half of the burn, to remove confounding variables between patients to determine the optimal burn dressing for partial thickness scald burns for pediatric patients. A partial thickness burn, also known as a second degree burn, extends into the top two layers of the skin, not passing the hypodermis. Our goal is to determine if Xeroform or Mepilex Ag is superior treatment for partial thickness burns in pediatric patients for healing time, appearance of scar, and patient pain and comfort during treatment and dressing changes.

Description:

The patients will be recruited at the Children's Hospital of Michigan burn center or clinic by research personnel. If a patient is determined to fit inclusion criteria, parental consent will be obtained using the attached consent form by one of the research personnel. If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. Also, a translator will be used to explain the full consent form used for English speaking patients. This form will be witnessed by a person who speaks the native language fluently. Only one parent will be required to sign consent as many patients only have one parent available in the hospital with them and this study involves only treatments that are current standard of care. If the patient is ages 7-12 years, an oral assent will be completed before participation in the study. If the patient is between ages 13-17, an assent form will be explained to them and their signature required to participate in the study. If they speak another language, assent will be obtained using a translator and the same methods listed above for parental consent. If the recruitment accrues beyond 4-6 non-english speaking participants, who speak a certain language, the consent forms will be translated into this language for future participants.

Study Protocol:

Once consent is obtained, and the patient is determined to be ready for a dressing application, one half of the extremity burn will be treated with Mepilex Ag and the other half of the extremity burn will be treated with Xeroform. Both of these treatments are current standard of care for a partial thickness scald burn in pediatric patients. The patients will be followed inpatient until they are discharged and then followed weekly at burn clinic appointments, the same care all of our burn patients receive. A survey will be administered to burn staff and patient's parents when the treatments are applied, at follow-up clinic appointments, and after the wound is healed completely. We will evaluate clinician and nurse ease of use, comfort of each dressing for the child, pain and itching associated with each dressing and dressing change, healing time, appearance of the scar after it is completely healed using the Vancouver Scar Scale, and parental satisfaction and ease of use for each dressing.

Data Collection and Evaluation:

A chart review will be performed for all patients to obtain demographic data including age, name, birth date, date of injury, injury details, the initial treatment applied if a different dressing was used before the patient was ready for application of Xeroform or Mepilex Ag, and any other pertinent information regarding the burn treatment. Study personnel and an attending physician will evaluate each patient at weekly follow-up visits or inpatient if the patient is being treated in the hospital. Survey results and other data will be evaluated after 10 patients complete treatment. Photographs taken as part of every burn patient's care may be reviewed as part of the study. These are obtained by medical photography and securely stored digitally. The Vancouver Scar Scale will be used for final evaluation of the healed scar after treatment is complete.

All data obtained in paper form will be stored in a locked filing cabinet in a locked office in the Pediatric Surgery Department and data obtained in digital form will be secure in a password protected file on the electronic medical record server.

Statistics will be performed using Statistical Package for Social Sciences (IBM version 22.0) and the statistical program R (r-project.org). The statistics to be performed for continuous variables (which are most of the assessment measures) will include a dependent groups analysis (e.g. paired samples t-test or robust analogue of this test such as Yuen's method for trimmed means, comparing medians, or bootstrap methods). The statistics to be performed for dichotomous measures will be the Sign test, which assesses differences in positive and negative outcomes for each treatment group.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients under age 17 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns to extremities.

• Burn of 1% TBSA or greater

• Within 48 hours of injury.

• Signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).

Exclusion Criteria:

• Flame burns

• age over 18 years

• infection

• skin graft or donor site

• burns greater than 48 hours old.

Related Conditions & MeSH terms

• Burns
• Second-degree Burn

Intervention

Device:
• Mepilex Ag (burn dressing)
Dressing for low to medium exuding burns and wounds.
• Xeroform Dressing
Standard of care dressing for low to medium exuding burns and wounds.

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Dykes PJ, Heggie R. The link between the peel force of adhesive dressings and subjective discomfort in volunteer subjects. J Wound Care. 2003 Jul;12(7):260-2. doi: 10.12968/jowc.2003.12.7.26567. — View Citation

Gotschall CS, Morrison MI, Eichelberger MR. Prospective, randomized study of the efficacy of Mepitel on children with partial-thickness scalds. J Burn Care Rehabil. 1998 Jul-Aug;19(4):279-83. doi: 10.1097/00004630-199807000-00002. — View Citation

Hollinworth H, Collier M. Nurses' views about pain and trauma at dressing changes: results of a national survey. J Wound Care. 2000 Sep;9(8):369-73. doi: 10.12968/jowc.2000.9.8.26282. — View Citation

O'Donovan DA, Mehdi SY, Eadie PA. The role of Mepitel silicone net dressings in the management of fingertip injuries in children. J Hand Surg Br. 1999 Dec;24(6):727-30. doi: 10.1054/jhsb.1999.0270. — View Citation

Platt AJ, Phipps A, Judkins K. A comparative study of silicone net dressing and paraffin gauze dressing in skin-grafted sites. Burns. 1996 Nov;22(7):543-5. doi: 10.1016/0305-4179(96)00035-6. — View Citation

Williams G, Withey S, Walker CC. Longstanding pigmentary changes in paediatric scalds dressed with a non-adherent siliconised dressing. Burns. 2001 Mar;27(2):200-2. doi: 10.1016/s0305-4179(00)00082-6. — View Citation

Winter GD (1975) Methods for the biological evaluation of dressings. In: Turner TD, Brain KR, eds. Surgical Dressings in the Hospital Environment. Surgical Dressings Research Unit, UWIST, Cardiff: 47-81

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar Evaluation	Vancouver Scar Scale: 0 is defined as normal in all instances; Vascularity: 0 to 3; Pigmentation: 0 to 3; Pliability/Elasticity: 0 to 5; Height: 0 to 3; Pain: 0 to 2; Itchiness: 0 to 2	burn injury healing time; up to 10 weeks
Secondary	Dressing Change Survey	Ease of application: 1 to 3; 3 is easiest; Pain during application: 1 to 10; 10 is most painful	during the burn injury treatment, up to 10 weeks

External Links

•   Descriptions of non-adherent dressings, their classification, and benefits
•   Pain at wound dressing change
•   Tool for assessing pain during dressing changes