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

A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds

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)

Study Overview

• Status: Withdrawn
• Conditions: Partial-thickness Burn
• Intervention / Treatment: Device: PermeaDerm; Device: Mepilex Ag

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Popp, MD; Phone Number: 409-770-6600; Email: danpopp@utmb.edu
• Study Contact Backup: Name: Debra Benjamin, RN; Phone Number: 409-770-6600; Email: dbenjami@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch Galveston
      • Contact: Debra Benjamin, RN; Phone Number: 409-770-6600; Email: dbenjami@utmb.edu
      • Contact: Daniel Popp, MD; Phone Number: 409-770-6600; Email: danielpopp@utmb.edu
      • Principal Investigator: Ludwik K Branski, MD, MMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 97 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PermeaDerm; Participants receive PermeaDerm dressing for wound treatment until wounds have healed completely	Device: PermeaDerm; Wound treatment with PermeaDerm
Active Comparator: Mepilex Ag; Participants receive Mepilex Ag dressing for wound treatment until wounds have healed completely	Device: Mepilex Ag; Wound treatment with Mepilex Ag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)	Pain assessment using Visual Analog Scale rating Pain scores ranging from 0-10 (8 years and older) OR Wong-Baker FACES Pain Rating Scale (3-7 years old). FACES stands for faces, since this rating scale shows faces from very happy to very unhappy. It ranges also from 0-10. Higher values indicating greater pain. The 0-10 scores for each scale are equivalent.	Changes over first 30 days post injury, using regression modeling for analysis.
Scar assessment with Patient and Observer Assessment Scale (POSAS)	Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.	at 1 month post injury
Scar assessment with Patient and Observer Assessment Scale (POSAS)	Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.	at 6 months post injury
Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	at 1 month post injury
Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	at 6 months post injury
Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	at 1 month post injury
Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	at 6 months post injury
Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	at 1 month post injury
Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	at 6 months post injury
Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	at 1 month post injury
Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	at 6 months post injury
Rate of Infection	Defined as bacterial growth of >10 to power of 5 in swab. Only taken when infection suspected.	at 1 month post burn
Cost-effectiveness	Number of dressing changes required until healing versus respective product costs (costs per cm square)	at 1 month post burn

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Ludwik K Branski, MD, The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PermeaDerm, Mepilex Ag, partial thickness burn wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 17-0315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data won't be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes