WoundsNCT01319149
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
An observational study of Wounds, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Observational
- 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
Study population: Patients with wounds who have been treated at Southwest Regional Wound Care Center.
Who may be able to join
- Patients who have been treated at SWRWCC during the months of March, April, or May 2010.
Who cannot join
- Patients who were not treated at SWRWCC during the time frame of March, April or May 2010.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Official title: A Retrospective Study Of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing
Read the detailed description
The null hypothesis would be that the introduction of molecular methods did not statistically affect patient outcomes. To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.
- Conditions
- Wounds
- Keywords
- molecular methods
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center and placed in a separate bin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing.
To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall D Wolcott, M.D., Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319149
- Sponsor's protocol ID
- 56-RW-020
- Status last verified
- Sep 2012
- First submitted
- 10 Mar 2011
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
- ClinicalTrials.gov ID
- NCT01319149
- Acronym / sponsor ID
- 56-RW-020
- Conditions
- Wounds
- Keywords
- molecular methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Mar 2011 (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.
A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing
Detailed description
The null hypothesis would be that the introduction of molecular methods did not statistically affect patient outcomes. To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center and placed in a separate bin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with wounds who have been treated at Southwest Regional Wound Care Center.
Key inclusion criteria (1 listed)
- Patients who have been treated at SWRWCC during the months of March, April, or May 2010.
Key exclusion criteria (1 listed)
- Patients who were not treated at SWRWCC during the time frame of March, April or May 2010.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing.
Time frame: 1 yr
To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.
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 13 Sep 2012.
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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.
Randall D Wolcott, M.D. principal investigator
Southwest Regional Wound Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Southwest Regional Wound Care Center 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 1 inclusion and 1 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 13 Sep 2012. 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?
The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing. (time frame: 1 yr). 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 13 Sep 2012.