PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds

NCT03613870 | Withdrawn FDA Device

• 1 other identifier: 17-0315
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)

Conditions

Partial-thickness Burn

Keywords

PermeaDerm, Mepilex Ag, partial thickness burn wounds

Outcome Measures

Primary Outcomes (1)

• Time to heal

  Time until wound is complete healed in days. A wound is considered as completely healed, when either PermeaDerm detaches on its own or no more dressings need to be applied in the Mepilex group. This time point is defined when approximately 95% of the wound shows epithelialization as determined by an experienced burn surgeon.

  up to 3 weeks after injury

Secondary Outcomes (13)

• Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)

  Changes over first 30 days post injury, using regression modeling for analysis.

• Scar assessment with Patient and Observer Assessment Scale (POSAS)

  at 1 month post injury

• Scar assessment with Patient and Observer Assessment Scale (POSAS)

  at 6 months post injury

• Scarring with DermaLab Combo device: Viscoelasticity

  at 1 month post injury

• Scarring with DermaLab Combo device: Viscoelasticity

  at 6 months post injury

Study Arms (2)

PermeaDerm

ACTIVE COMPARATOR

Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely

Device: PermeaDerm

Mepilex Ag

ACTIVE COMPARATOR

Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely

Device: Mepilex Ag

Interventions

PermeaDerm DEVICE

Wound treatment with PermeaDerm

PermeaDerm

Mepilex Ag DEVICE

Wound treatment with Mepilex Ag

Mepilex Ag

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Superficial partial thickness burn injury due to flame burn, scald injury or contact burn that does not require excision and grafting
• Total Body Surface Area burned (TBSA) total ≤30 %
• Admission within 72 hours of burn injury
• Non-infected wound as diagnosed by the attending physician upon admission
• Treated as an outpatient or in an observational setting

You may not qualify if:

• Patient younger than 6 months
• Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
• Admission time greater than 72 hours after the injury
• Wounds noted to be infected at admission
• Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other pseudo eschar-forming topical agents
• Pregnancy/lactation

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Officials

• Ludwik K Branski, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: July 19, 2018
• Primary Completion: December 1, 2018
• Study Completion: July 11, 2019
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share