NCT02982096

Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique

Randomized Controlled Pilot Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Lehigh Valley Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if healing occurs within 21 days of treatment with the use of the CellutomeTM device for fractional epidermal micro grafting compared with standard acellular techniques (creams and membrane dressings). Healing will be determined by time to ≥90% epithelialization within 21 days of treatment. Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to standard techniques without application of skin cells (epidermal grafts = acellular) and will be measured twelve months post treatment application, ± 6 months.

Detailed description

Hypothesis: The use of epidermal blister grafting by the CellutomeTM device in the treatment of superficial and mid-dermal burn wounds will demonstrate a difference in time to healing compared to burn wounds treated with standard acellular technique. Primary objective: Determine if the use of the CellutomeTM device will demonstrate a difference in healing time compared to standard acellular technique. Final cosmetic outcomes (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be assessed and described at 12 months ± 6 months post treatment. Secondary objectives: * Determine if donor sites have any visible scarring with the use of the CellutomeTM. * Determine acute outcomes of therapy such as time to healing as assessed by ≥90% epithelialization. * Determine chronic outcomes of therapy (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale (POSAS), erythema, pigmentation, elasticity, thickness, and sensation).

Conditions

• Burn Wound

Interventions

Type	Name	Description
DEVICE	Cellutome Device	Use of FDA approved Cellutome treatment on burn wounds
OTHER	Standard of Care	Acellular burn wound management

Timeline

• Start date: 2016-08-23
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-12-05
• Last updated: 2023-04-10

Locations

1 site across 1 country: United States