Wound Chronic DrainingNCT02142426
A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients
An observational study of Wound Chronic Draining, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Chronic Draining
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic wound patients
Who may be able to join
- -Patients with chronic wounds.
Who cannot join
- -Patients without chronic wounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.
Read the detailed description
The information was processed from culture results that were processed to compile an antibiogram for a laboratory.
- Conditions
- Wound Chronic Draining
- Keywords
- wound chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve selection of systemic antibiotics based on results using molecular diagnostics.
The study elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds. It evaluated samples from different regions, different types of wounds, different outcomes, and longitudinal data if multiple samples were sent over time from a single individual.
Measured: 1 year
Secondary outcomes (1)
2. Data Collection: The molecular wound cultures have been performed on thousands of patients from around the country. The information from the culture results that were processed were used to compile an antibiogram for a laboratory.
There are many geographic regions which have a number of samples which could be analyzed and compared to other geographic regions yielding valuable insight into the microbiology of chronic wounds.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
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 Wound Chronic DrainingStudies 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
- Time perspective
- Retrospective
- Enrolment
- 2,000 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, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142426
- Sponsor's protocol ID
- 56-RW-021
- Status last verified
- Nov 2015
- First submitted
- 13 Sep 2011
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dowd SE, Wolcott RD, Kennedy J, Jones C, Cox SB. Molecular diagnostics and personalised medicine in wound care: assessment of outcomes. J Wound Care. 2011 May;20(5):232, 234-9. doi: 10.12968/jowc.2011.20.5.232.
PubMed 21647068
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients
- ClinicalTrials.gov ID
- NCT02142426
- Acronym / sponsor ID
- 56-RW-021
- Conditions
- Wound Chronic Draining
- Keywords
- wound chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 May 2014 (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 was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.
Detailed description
The information was processed from culture results that were processed to compile an antibiogram for a laboratory.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic wound patients
Key inclusion criteria (1 listed)
- -Patients with chronic wounds.
Key exclusion criteria (1 listed)
- -Patients without chronic wounds.
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
Improve selection of systemic antibiotics based on results using molecular diagnostics.
Time frame: 1 year
The study elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds. It evaluated samples from different regions, different types of wounds, different outcomes, and longitudinal data if multiple samples were sent over time from a single individual.
1 secondary outcome
2. Data Collection: The molecular wound cultures have been performed on thousands of patients from around the country. The information from the culture results that were processed were used to compile an antibiogram for a laboratory.
Time frame: 1 year
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 26 Nov 2015.
- Results publication: PubMed 21647068Dowd SE, Wolcott RD, Kennedy J, Jones C, Cox SB. Molecular diagnostics and personalised medicine in wound care: assessment of outcomes. J Wound Care. 2011 May;20(5):232, 234-9. doi: 10.12968/jowc.2011.20.5.232.
Related trials for Wound Chronic Draining
Not yet recruitingPhase 2
Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds
Wound Chronic Draining, Wound Closure
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, MD 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 Wound Chronic Draining, 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 26 Nov 2015. 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?
Improve selection of systemic antibiotics based on results using molecular diagnostics. (time frame: 1 year). 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 NCT02142426, 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 26 Nov 2015.