Wound HealingNCT00968994
Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
A study testing The exSALT™ SD7 Wound Dressing and Xeroform® Petrolatum Dressing in people with Wound Healing and Wound Infection, run by Exciton Technologies Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound Healing, Wound Infection
- What is being tested?
- The exSALT™ SD7 Wound Dressing and Xeroform® Petrolatum Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Heather Shankowsky, RN, 780-407-3408, Heather.Shankowsky@albertahealthservices.ca
Edward E Tredget, MD, MSC, 780-407-6979, etredget@ualberta.ca
About this study
Official title: A Randomized, Site-Matched, Controlled Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
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.
Read the detailed description
Autologous skin grafting is a common procedure required in the care of burn and plastic surgery patients where the harvesting of autologous skin grafts results in the creation of a partial thickness wound known as a donor site. The donor site healing time can affect the length of hospitalization and subject survival.
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
- Wound Healing, Wound Infection
- Being tested
- The exSALT™ SD7 Wound Dressing, Xeroform® Petrolatum Dressing
- Keywords
- Wound Healing, Wound Infection
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exSALT™ SD7 Wound DressingDevice
Also called K083870
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 DressingDevice
Also called K973507
Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
| Study group | Role | What they receive |
|---|---|---|
| exSALT SD7™ Wound Dressing | Experimental | 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). Receives: Device: The exSALT™ SD7 Wound Dressing |
| Xeroform® Petrolatum Dressing | Active comparator | 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. Receives: Device: Xeroform® Petrolatum Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the proportion of donor sites healed.
Measured: 10 days
Evaluate the proportion of donor sites healed.
Measured: 14 Days
Secondary outcomes (5)
Time to re-epithelialization.
Measured: 12 weeks
Pain with dressing changes and mobilization.
Measured: 12 weeks
Assessments that quantify ease of use.
Measured: 12 weeks
Resource utilization and safety.
Measured: 12 weeks
Appearance and long term cosmetic results.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exciton Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alberta Heritage Foundation for Medical Research, Epidemiology Coordinating and Research Centre, Canada, Smart Medical Research Inc.
- Investigators
- Ruth Collins-Nakai, MD, MBA, Study director, Exciton Technologies Inc.Edward E Tredget, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968994
- Sponsor's protocol ID
- PR-0004
- Status last verified
- Dec 2009
- First submitted
- 27 Aug 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Site-Matched, Controlled Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
- ClinicalTrials.gov ID
- NCT00968994
- Acronym / sponsor ID
- PR-0004
- Conditions
- Wound Healing, Wound Infection
- Keywords
- Wound Healing, Wound Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Exciton Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alberta Heritage Foundation for Medical Research, Epidemiology Coordinating and Research Centre, Canada, Smart Medical Research Inc.
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autologous skin grafting is a common procedure required in the care of burn and plastic surgery patients where the harvesting of autologous skin grafts results in the creation of a partial thickness wound known as a donor site. The donor site healing time can affect the length of hospitalization and subject survival.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exSALT SD7™ Wound Dressing | Experimental | Device: The exSALT™ SD7 Wound DressingThe 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 comparator | Device: Xeroform® Petrolatum DressingXeroform® 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The exSALT™ SD7 Wound DressingAlso: K083870The 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. | Device | exSALT SD7™ Wound Dressing |
| Xeroform® Petrolatum DressingAlso: K973507Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. | Device | Xeroform® Petrolatum Dressing |
Primary outcome
Evaluate the proportion of donor sites healed.
Time frame: 10 days
Evaluate the proportion of donor sites healed.
Time frame: 14 Days
5 secondary outcomes
Time to re-epithelialization.
Time frame: 12 weeks
Pain with dressing changes and mobilization.
Time frame: 12 weeks
Assessments that quantify ease of use.
Time frame: 12 weeks
Resource utilization and safety.
Time frame: 12 weeks
Appearance and long term cosmetic results.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Collins-Nakai, MD, MBA study director
Exciton Technologies Inc.
Edward E Tredget, MD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The exSALT™ SD7 Wound Dressing and Xeroform® Petrolatum Dressing in people with Wound Healing and Wound Infection, run by Exciton Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Simon, BSc (780-248-5884, JSimon@Excitontech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the proportion of donor sites healed. (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.