BurnPhase 2/3SoaksNCT00675922
Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks
A Phase 2/3 study testing Sulfamylon 5% and Silver Nitrate Soaks in people with Burn, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay). Read more about this study
- Who is it for?
- Ages 1 day to 90 years
- Conditions the study is for
- Burn
- What is being tested?
- Sulfamylon 5% and Silver Nitrate Soaks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1995to May 2008
- Phase
- Phase 2/3
- 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 1 day to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn Injury requiring excisional therapy
- Hospitalization required until wounds are closed
Who cannot join
- Known hypersensitivity to products
- Outpatient treatment for burn injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).
Read the detailed description
Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.
- Conditions
- Burn
- Being tested
- Sulfamylon 5% and Silver Nitrate Soaks
- Keywords
- Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate
- Medical subject headings
- Burns, Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfamylon 5% and Silver Nitrate SoaksDrug
Also called Sulfamylon, Silver Nitrate
Application of Sulfamylon and Silver Nitrate Solution to burn wound daily
| Study group | Role | What they receive |
|---|---|---|
| Sulfamylon 5% and Silver Nitrate Soaks | Experimental | Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization. Receives: Drug: Sulfamylon 5% and Silver Nitrate Soaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.
Measured: Acute hospitalization following burn injury: admission to discharge (1-20 weeks)
Secondary outcomes (1)
Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data for this outcome. Although peer-reviewed articles have been located that reference NCT00675922 it is not clear and verifiable (without access to the actual study-related data) what the results for this outcome.
Measured: Admission to burn unit to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJul 1995
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Data inconclusive.
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.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675922
- Sponsor's protocol ID
- 95-096
- Acronym
- Soaks
- Status last verified
- Jun 2023
- First submitted
- 26 Dec 2007
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds
- ClinicalTrials.gov ID
- NCT00675922
- Acronym / sponsor ID
- Soaks / 95-096
- Conditions
- Burn
- Keywords
- Burn, Wounds, Wound infection, Topical antimicrobials, Cerium, Dakins, Sulfamylon Soaks, Silver Nitrate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data inconclusive.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jul 1995
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).
Detailed description
Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulfamylon 5% and Silver Nitrate Soaks | Experimental | Drug: Sulfamylon 5% and Silver Nitrate SoaksApplication of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization. |
Who may qualify
- Ages
- 1 day to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Burn Injury requiring excisional therapy
- Hospitalization required until wounds are closed
Key exclusion criteria (2 listed)
- Known hypersensitivity to products
- Outpatient treatment for burn injury
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 |
|---|---|---|
| Sulfamylon 5% and Silver Nitrate SoaksAlso: Sulfamylon, Silver NitrateApplication of Sulfamylon and Silver Nitrate Solution to burn wound daily | Drug | Sulfamylon 5% and Silver Nitrate Soaks |
Primary outcome
Infection Rate
Time frame: Acute hospitalization following burn injury: admission to discharge (1-20 weeks)
Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.
1 secondary outcome
Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients
Time frame: Admission to burn unit to discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David N Herndon, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sulfamylon 5% and Silver Nitrate Soaks in people with Burn, run by The University of Texas Medical Branch, Galveston 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Jun 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2013). 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?
Infection Rate (time frame: Acute hospitalization following burn injury: admission to discharge (1-20 weeks)). 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 22 Jun 2023.