A Comparison of Redrubber Versus Penrose Drains (redrubber)
Primary Purpose
Odontogenic Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
penrose drain
red rubber drain
Sponsored by

About this trial
This is an interventional treatment trial for Odontogenic Infection focused on measuring drainage, irrigation
Eligibility Criteria
Inclusion Criteria:
- age 16 and older
Exclusion Criteria:
- none
Sites / Locations
- Grady Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2
1
Arm Description
This group will have a red rubber drain(s) placed during surgery. This drain(s) will be irrigated intra and post-operatively
This group will have a penrose drain(s) placed during surgery to facilitate drainage post-operatively. This drain (s) will not be irrigated.
Outcomes
Primary Outcome Measures
Resolution of infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00645957
Brief Title
A Comparison of Redrubber Versus Penrose Drains
Acronym
redrubber
Official Title
A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontogenic Infection
Keywords
drainage, irrigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
This group will have a red rubber drain(s) placed during surgery. This drain(s) will be irrigated intra and post-operatively
Arm Title
1
Arm Type
Active Comparator
Arm Description
This group will have a penrose drain(s) placed during surgery to facilitate drainage post-operatively. This drain (s) will not be irrigated.
Intervention Type
Procedure
Intervention Name(s)
penrose drain
Intervention Description
incision and drainage of the infection with placement of a penrose drain
Intervention Type
Procedure
Intervention Name(s)
red rubber drain
Intervention Description
incision and drainage of infection and placement of a red rubber drain
Primary Outcome Measure Information:
Title
Resolution of infection
Time Frame
several days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 16 and older
Exclusion Criteria:
none
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
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A Comparison of Redrubber Versus Penrose Drains
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