Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

Burns Clinical Trial

Official title:

Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061502
• Other study ID #: XSMP-014
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 1, 2010
• Last updated: December 9, 2010
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Vomaris Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Wounds resulting from skin graft

• Split thickness wound

• Wound size greater than 2x2 cm

• Wounds must be =5 cm away from all other wounds

• Participant agrees to participate in follow-up evaluation

• Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study

• Participant is to receive another topical antimicrobial agent other than the study dressing

• Participant with sensitivity or adverse reactions to silver or zinc

• Pregnancy or nursing an infant or child

• Immunosuppression

• Active or systemic infection

• Peripheral vascular occlusive disease

• Collagen vascular disease

• Connective tissue disease

• Participant undergoing active cancer chemotherapy

• Chronic steroid use

• Decision impairment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Wound Healing

Intervention

Device:
• Procellera (Bioelectric Wound Dressing)
Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed
• Opsite (Transparent Adhesive Dressing)
Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.

Locations

Country	Name	City	State
United States	Blodgett Hospital	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vomaris Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare epithelialization over time		3 months	Yes
Secondary	To compare patient reported perception of pain		3 months	Yes
Secondary	To compare scarring		3 months	No