BurnsNCT00137215
Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites
A study testing Silverlon in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Silverlon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older; male or female.
- Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities
- Burns do not involve the harvesting area
- Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization
- Subject agrees to participate in follow-up evaluations
Who cannot join
- Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.
- Cellulitis or other infection of potential donor site
- Previously harvested donor site
- Subject with greater than 30% TBSA burns
- Subjects with sensitivity to silver or nylon
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-6315
About this study
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.
Read the detailed description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.
- Conditions
- Burns
- Being tested
- Silverlon
- Keywords
- burns, donor site care, Silverlon dressing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverlonDevice
dressing for donor site mamagement
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Device: Silverlon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform
Measured: 14 days
Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform
Measured: 30-45 days
Secondary outcomes (1)
Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJan 2006
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Investigators
- Michael Albrecht, MD, Principal investigator, US Army Institute of Surgical ResearchSteven E Wolf, MD, Study director, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137215
- Sponsor's protocol ID
- H-04-018
- Status last verified
- Jul 2008
- First submitted
- 25 Aug 2005
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004 Mar-Apr;25(2):192-6. doi: 10.1097/01.bcr.0000112331.72232.1b.
PubMed 15091147
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites
- ClinicalTrials.gov ID
- NCT00137215
- Acronym / sponsor ID
- H-04-018
- Conditions
- Burns
- Keywords
- burns, donor site care, Silverlon dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Jan 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Aug 2005 (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.
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.
Detailed description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Silverlon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older; male or female.
- Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities
- Burns do not involve the harvesting area
- Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization
Key exclusion criteria (8 listed)
- Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.
- Cellulitis or other infection of potential donor site
- Previously harvested donor site
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 |
|---|---|---|
| Silverlondressing for donor site mamagement | Device | A |
Primary outcome
Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform
Time frame: 14 days
Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform
Time frame: 30-45 days
1 secondary outcome
Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
- Background: PubMed 15091147Bowler PG, Jones SA, Walker M, Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabil. 2004 Mar-Apr;25(2):192-6. doi: 10.1097/01.bcr.0000112331.72232.1b.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
Michael Albrecht, MD principal investigator
US Army Institute of Surgical Research
Steven E Wolf, MD study director
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silverlon in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2008. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform (time frame: 14 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?
On the ClinicalTrials.gov record for NCT00137215, which also lists 1 linked publication.
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 28 Jul 2008.