- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645957
A Comparison of Redrubber Versus Penrose Drains (redrubber)
November 19, 2013 updated by: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections
All patients presenting to Grady Memorial Hospital with an odontogenic (dental) infection that requires admission to the hospital and incision and drainage will be eligible for inclusion in this pilot study.
The surgical method used for incision and drainage will be determined by the attending surgeon who will operate on the patient.
The surgical procedure is a simple and universally standardized involving one or more small incisions in the mouth or in the upper neck and the placement of a drain(s) within the infected area to facilitate continued drainage of pus.
Subjects will be randomized to either a red rubber or penrose drain(s).
The drains are placed through the mouth or upper neck depending on the location of the infection and typically remain in place until the drainage has stopped (several days).
All drains are secured with a single stitch through the gum or skin.
The drain(s) will be removed bedside by removing a single suture and gently withdrawing the drain.
The timing of this is determined by the clinical picture although this typically occurs within the first week.
This is not a painful procedure.
Currently some surgeons place red rubber drains which, after placement, allow the infection not only to drain but also be irrigated with saline both during the surgery and in the immediate post-operative period.
Other surgeons place penrose drains, which, after placement, continue to allow the infection to drain but cannot be irrigated.
Red rubber drains require daily irrigation and as such are labor intensive.
Furthermore, drains that are irrigated may continue to drain the saline irrigant in the many hours after irrigation that upon clinical inspection may be difficult to distinguish from sero-sanguinous (pus) drainage.
It is daily inspection of the drainage (or lack thereof) which determines the appropriate time to remove the drain(s).
This in turn may influence time to discharge and ultimately hospital costs
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 16 and older
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
This group will have a red rubber drain(s) placed during surgery.
This drain(s) will be irrigated intra and post-operatively
|
incision and drainage of infection and placement of a red rubber drain
|
ACTIVE_COMPARATOR: 1
This group will have a penrose drain(s) placed during surgery to facilitate drainage post-operatively.
This drain (s) will not be irrigated.
|
incision and drainage of the infection with placement of a penrose drain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of infection
Time Frame: several days
|
several days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
March 5, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (ESTIMATE)
March 28, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2013
Last Update Submitted That Met QC Criteria
November 19, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00006249
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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