BurnsNCT00558701
Microcurrent for Healing Autogenous Skin Donor Sites
A study testing Microcurrent stimulator and Silverlon Wound Contact Dressing in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Microcurrent stimulator and Silverlon Wound Contact Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- between 18-65 years of age
- burn less than 30% total body surface area
- burns not involving donor site area
- you need skin grafting to cover burns
- agree not to use other electronic devices that generate current during your study participation
- agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed
Who cannot join
- you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease
- you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin
- you have an infection of the skin or your bloodstream
- you are pregnant or nursing
- you are sensitive or allergic to silver or nylon
- your burn wounds are more than 30% of your total body surface area
- your site was previously harvested for grafting
- you have an implantable pacemaker device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites
This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.
Read the detailed description
The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.
- Conditions
- Burns
- Being tested
- Microcurrent stimulator, Silverlon Wound Contact Dressing
- Keywords
- burns, donor site, healing, microcurrent
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent stimulatorDevice
Microcurrent stimulation from 15-50 microamps
Silverlon Wound Contact DressingDevice
Silver coated nylon dressing FDA approved for use on donor sites in burn patients
| Study group | Role | What they receive |
|---|---|---|
| Microcurrent Stimulator + Silverlon | Active comparator | Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. Receives: Device: Microcurrent stimulator; Device: Silverlon Wound Contact Dressing |
| Silverlon alone | Sham comparator | Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) Receives: Device: Silverlon Wound Contact Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Wound Healing
Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Collaborators
- Samueli Institute for Information Biology
- Responsible party
- Sponsor
- Investigators
- Leopoldo C Cancio, MD, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558701
- Sponsor's protocol ID
- H-07-003
- Other IDs
- I.2007.128
- Status last verified
- Aug 2015
- First submitted
- 13 Nov 2007
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kauvar DS, Cancio LC, Wolf SE, Wade CE, Holcomb JB. Comparison of combat and non-combat burns from ongoing U.S. military operations. J Surg Res. 2006 May 15;132(2):195-200. doi: 10.1016/j.jss.2006.02.043. Epub 2006 Mar 31.
PubMed 16580688Malin EW, Galin CM, Lairet KF, Huzar TF, Williams JF, Renz EM, Wolf SE, Cancio LC. Silver-coated nylon dressing plus active DC microcurrent for healing of autogenous skin donor sites. Ann Plast Surg. 2013 Nov;71(5):481-4. doi: 10.1097/SAP.0b013e31829d2311.
PubMed 23903090
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites
- ClinicalTrials.gov ID
- NCT00558701
- Acronym / sponsor ID
- H-07-003
- Conditions
- Burns
- Keywords
- burns, donor site, healing, microcurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Collaborators
- Samueli Institute for Information Biology
- Study start
- Dec 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.
Detailed description
The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcurrent Stimulator + Silverlon | Active comparator | Device: Microcurrent stimulator, Device: Silverlon Wound Contact DressingPatients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator. |
| Silverlon alone | Sham comparator | Device: Silverlon Wound Contact DressingPatients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 18-65 years of age
- burn less than 30% total body surface area
- burns not involving donor site area
- you need skin grafting to cover burns
- agree not to use other electronic devices that generate current during your study participation
Key exclusion criteria (8 listed)
- you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease
- you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin
- you have an infection of the skin or your bloodstream
- you are pregnant or nursing
- you are sensitive or allergic to silver or nylon
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 |
|---|---|---|
| Microcurrent stimulatorMicrocurrent stimulation from 15-50 microamps | Device | Microcurrent Stimulator + Silverlon |
| Silverlon Wound Contact DressingSilver coated nylon dressing FDA approved for use on donor sites in burn patients | Device | Microcurrent Stimulator + Silverlon, Silverlon alone |
Primary outcome
Time to Wound Healing
Time frame: 20 days
Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16580688Kauvar DS, Cancio LC, Wolf SE, Wade CE, Holcomb JB. Comparison of combat and non-combat burns from ongoing U.S. military operations. J Surg Res. 2006 May 15;132(2):195-200. doi: 10.1016/j.jss.2006.02.043. Epub 2006 Mar 31.
- Derived from this study: PubMed 23903090Malin EW, Galin CM, Lairet KF, Huzar TF, Williams JF, Renz EM, Wolf SE, Cancio LC. Silver-coated nylon dressing plus active DC microcurrent for healing of autogenous skin donor sites. Ann Plast Surg. 2013 Nov;71(5):481-4. doi: 10.1097/SAP.0b013e31829d2311.
- Individual participant dataSharing planned: No
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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.
Leopoldo C Cancio, MD principal investigator
United States 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 Microcurrent stimulator and Silverlon Wound Contact Dressing 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 6 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Wound Healing (time frame: 20 days). 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 NCT00558701, which also lists 2 linked publications.
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 6 Jun 2016.