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

NCT04149808 | Withdrawn FDA Device

• 1 other identifier: 061019MP2E
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Second-degree Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dressing Change Survey

  during the burn injury treatment, up to 10 weeks

Study Arms (2)

Xeroform Control

ACTIVE COMPARATOR

A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with xeroform dressing, which is the standard of care.

Device: Xeroform Dressing

Mepilex Ag Intervention

EXPERIMENTAL

A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with Mepilex Ag; the product being tested.

Device: Mepilex Ag (burn dressing)

Interventions

Mepilex Ag (burn dressing) DEVICE

Dressing for low to medium exuding burns and wounds.

Mepilex Ag Intervention

Xeroform Dressing DEVICE

Standard of care dressing for low to medium exuding burns and wounds.

Xeroform Control

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Flame burns
• age over 18 years
• infection
• skin graft or donor site
• burns greater than 48 hours old.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Related 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.

  PMID: 9882058 BACKGROUND

• 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.

  PMID: 12894697 BACKGROUND

• 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.

  PMID: 9710723 BACKGROUND

• 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.

  PMID: 11933365 BACKGROUND

• 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.

  PMID: 10672813 BACKGROUND

• 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.

  PMID: 8909755 BACKGROUND

• 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.

  PMID: 11226664 BACKGROUND

• 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

  BACKGROUND

Related Links

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

Study Officials

• Elika Ridelman, PhD

  Wayne State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study was never initiated and study was terminated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Patients under age 18 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns.The burn must be at least 1% total body surface area (TBSA) or greater. The burn is divided approximately in half, with 50% of the wound receiving xeroform dressing and the remaining 50% receiving Mepilex Ag. Patients must present within 48 hours of injury. Patients must have a signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)