Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
A Randomized, Site-Matched, Controlled Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
1 other identifier
interventional
25
1 country
1
Brief Summary
This randomized, controlled trial is designed to evaluate split-thickness donor sites treated with exSALT SD7™ compared to donor sites treated with Xeroform®. For the purpose of this study, subjects enrolled will have selected donor sites or portions of donor sites designated as "Test Sites." The selected locations will be randomly assigned treatment with either the Test Dressing or the Control Dressing. The primary objective of the trial will be to quantify the proportion of the donor sites in each group that are healed at 10 and 14 days. Secondary objectives will include: time to re-epithelialization, pain with dressing changes and mobilization, ease of use, resource utilization and safety, as well as quality of healing and overall cosmetic result. A total of 25 subjects will be enrolled in the trial. The trial duration will be 12 weeks. For the purposes of this trial, healing will be defined as ≥ 90% re-epithelialization and must be visually confirmed by the investigator or designate and two other people (i.e., research nurse, burn resident, member of the Wound Care Team). The maximum time to evaluate healing will be 14 days +/-2 days. A final visit will be conducted at 12 weeks for safety and to evaluate the quality of healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
August 31, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedDecember 24, 2009
December 1, 2009
1 year
August 27, 2009
December 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate the proportion of donor sites healed.
10 days
Evaluate the proportion of donor sites healed.
14 Days
Secondary Outcomes (5)
Time to re-epithelialization.
12 weeks
Pain with dressing changes and mobilization.
12 weeks
Assessments that quantify ease of use.
12 weeks
Resource utilization and safety.
12 weeks
Appearance and long term cosmetic results.
12 weeks
Study Arms (2)
exSALT SD7™ Wound Dressing
EXPERIMENTALThe exSALT™ SD7 Wound Dressing provides an antimicrobial barrier that inhibits microbial growth in the dressing. The exSALT™ SD7 Wound Dressing consists of 3 layers: two non-adherent polyethylene mesh wound contact layers and one absorbent core made of polyester. All three layers are silver coated. The concentration of silver on the exSALT™ SD7 Wound Dressing is approximately 0.4 mg/cm2 (2.5% w/w).
Xeroform® Petrolatum Dressing
ACTIVE COMPARATORXeroform® Petrolatum Dressing (Xeroform® / Control Dressing) is fine mesh gauze impregnated with 3% Bismuth Tribromophenate in a special petrolatum blend. The dressing is a non adherent dressing that clings and conforms to all body parts.
Interventions
The exSALT™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
Eligibility Criteria
You may qualify if:
- signed or verbal informed consent provided
- are 18 to 65 years of age
- scheduled to undergo a split-thickness skin graft (autograft) that will result in a donor site or sites that are; a first time harvest and includes primarily the anterior including medial and lateral aspects of the anterior portion(s) of the thigh(s) with either; a single donor site that is a minimum of 8 x 20 cm or two donor sites are both a minimum of 8 x 8 cm and the resulting test sites are generally comparable in size and wound characteristics.
- requires hospitalization for initial treatment
You may not qualify if:
- require full thickness graft
- known skin sensitivity to any of the dressing components
- poor prognosis and who are unlikely to survive the trial period
- participating in another concurrent trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exciton Technologies Inc.lead
- Alberta Heritage Foundation for Medical Researchcollaborator
- Epidemiology Coordinating and Research Centre, Canadacollaborator
- Smart Medical Research Inc.collaborator
Study Sites (1)
The University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruth Collins-Nakai, MD, MBA
Exciton Technologies Inc.
- PRINCIPAL INVESTIGATOR
Edward E Tredget, MD, MSc
University of Alberta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 27, 2009
First Posted
August 31, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
December 24, 2009
Record last verified: 2009-12