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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061502

Enrollment

Registered

2010-02-03

Start date

2009-09-30

Completion date

2010-11-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Wound Healing

Keywords

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

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.

Interventions

DEVICEProcellera (Bioelectric Wound Dressing)

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

DEVICEOpsite (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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare epithelialization over time	3 months

Secondary

Measure	Time frame
To compare patient reported perception of pain	3 months
To compare scarring	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026