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

NCT ID: NCT03613870

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2019-07-11

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)

Detailed Description

In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs.

60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting.

Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy.

Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).

Conditions

Partial-thickness Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PermeaDerm

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

Group Type: ACTIVE_COMPARATOR

PermeaDerm

Intervention Type: DEVICE

Wound treatment with PermeaDerm

Mepilex Ag

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

Group Type: ACTIVE_COMPARATOR

Mepilex Ag

Intervention Type: DEVICE

Wound treatment with Mepilex Ag

Interventions

PermeaDerm

Wound treatment with PermeaDerm

Intervention Type: DEVICE

Mepilex Ag

Wound treatment with Mepilex Ag

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ludwik K Branski, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Other Identifiers

17-0315

Identifier Type: -

Identifier Source: org_study_id