Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

Acute Wounds Clinical Trial

Official title:

Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816101
• Other study ID #: XSMP-002
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2008
• Last updated: March 4, 2011
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: March 2011
• Source: Vomaris Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test.

• Wound size greater than 1x1 cm

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

• Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening

• 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

• Diabetes

• Venous stasis ulcers

• Participant undergoing active cancer chemotherapy

• Chronic steroid use

• Decision impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Wounds

Intervention

Other:
• Procellera™ Antimicrobial Dressing
Dressing indicated for partial and full-thickness wounds.
• Mepilex® Border Lite
Self-adherent foam dressing

Device:
• Adhesive Bandage
Adhesive bandage

Locations

Country	Name	City	State
United States	Sheftel Associates Dermatology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vomaris Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Experienced 50% or Greater Wound Healing	Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported	3 Weeks	No
Secondary	Number of Patients Reporting Pain	Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.	3 Weeks	No
Secondary	Erythema at Week 3	At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with "0" being "No erythema", "1" being "Very slight erythema", "2" being "Well defined erythema", "3" being "Moderate to severe erythema" and 4 being "Severe erythema to slight eschar formation"	3 Weeks	No