Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
NCT ID: NCT00968994
Last Updated: 2009-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
25 participants
INTERVENTIONAL
2009-12-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The literature reports the use of a variety of donor site dressing materials including fine mesh gauze, polyurethane film, synthetic fiber and hydrocolloids (Kilinc, Sensoz et al. 2001). The literature reports what might be considered the optimal donor site dressing attributes. These attributes would include: minimizing pain, velocity in healing, minimizing bacterial growth and simplicity in use (Rakel, Bermel et al. 1998).
However, none of the available dressing products are entirely satisfactory. Fine mesh gauze (FMG) is the donor site dressing used at many burn centers, as it is inexpensive, can be placed on posterior donor sites, does not require a margin of intact skin and allows large amounts of exudate to drain away from the donor site.
However, FMG does not have any inherent anti-infective properties and provides a dry environment for wound healing. Xeroform® Petrolatum Dressing resembles FMG physically except that it contains 3% xeroform (bismuth tribromophenate) which exerts some antibacterial effect (Feldman, Rogers et al. 1991). Xeroform® Petrolatum Dressing is the standard donor site dressing in the Firefighters' Burn Treatment Unit (3C2 WMC) and Plastic Surgery Unit (3D3 WMC) and has been selected as the control treatment (Control Dressing).
Research evidence demonstrates that partial thickness wounds re-epithelialize more rapidly in a moist environment that is free from infection (Alper 1986; Alvarez 1988). In an effort to provide an improved method of dressing wounds and donor sites, exSALT SD7™ has been proposed as an alternative dressing (Test Dressing). The dressing is intended to reduce pain and discomfort and improve the re-epithelialization process by providing a moist environment. The model outlined in this protocol provides the basis for a controlled comparison of wound healing and re-epithelialization in a clean partial thickness wound that allows us to compare the healing rate and quality of the Test Dressing compared to our standard of care to determine safety and efficacy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
exSALT SD7™ Wound Dressing
The 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).
The exSALT™ SD7 Wound Dressing
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.
Xeroform® Petrolatum Dressing
Xeroform® 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.
Xeroform® Petrolatum Dressing
Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The exSALT™ SD7 Wound Dressing
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.
Xeroform® Petrolatum Dressing
Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Heritage Foundation for Medical Research
OTHER
Epidemiology Coordinating and Research Centre, Canada
OTHER
Smart Medical Research Inc.
INDUSTRY
Exciton Technologies Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Exciton Technologies Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ruth Collins-Nakai, MD, MBA
Role: STUDY_DIRECTOR
Exciton Technologies Inc.
Edward E Tredget, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Heather Shankowsky, RN
Role: primary
Edward E Tredget, MD, MSC
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR-0004
Identifier Type: -
Identifier Source: org_study_id