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

NCT01061502 | Completed Phase 1 DMC

• 1 other identifier: XSMP-014
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burns; Wound Healing

Keywords

Burns; Wounds and Injuries; Skin Grafts, Bioelectric; Grafting, skin

Outcome Measures

Primary Outcomes (1)

• To compare epithelialization over time

  3 months

Secondary Outcomes (2)

• To compare patient reported perception of pain

  3 months

• To compare scarring

  3 months

Study Arms (2)

Procellera Wound Dressing

EXPERIMENTAL

Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed

Device: Procellera (Bioelectric Wound Dressing)

Opsite Transparent Adhesive Dressing

ACTIVE COMPARATOR

Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed

Device: Opsite (Transparent Adhesive Dressing)

Interventions

Procellera (Bioelectric Wound Dressing) DEVICE

Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed

Also known as: Procellera, PROSIT, Procellera Wound Dressing, Procellera Device

Procellera Wound Dressing

Opsite (Transparent Adhesive Dressing) DEVICE

Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.

Also known as: Opsite Dressing

Opsite Transparent Adhesive Dressing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vomaris Innovations: lead

Study Sites (1)

Blodgett Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Burns; Wounds and Injuries

Study Officials

• Andrew L Blount, MD

  Blodgett Hospital

  PRINCIPAL INVESTIGATOR

• Richard Wilcox, MD

  Blodgett Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 3, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

US (1)