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A Comparison of Redrubber Versus Penrose Drains (redrubber)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645957
First Posted: March 28, 2008
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
  Purpose
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

Condition Intervention
Odontogenic Infection Procedure: penrose drain Procedure: red rubber drain

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections

Further study details as provided by Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University:

Primary Outcome Measures:
  • Resolution of infection [ Time Frame: several days ]

Enrollment: 50
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: red rubber drain
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.
Procedure: penrose drain
incision and drainage of the infection with placement of a penrose drain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 16 and older

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645957


Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
  More Information

Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00645957     History of Changes
Other Study ID Numbers: IRB00006249
First Submitted: March 5, 2008
First Posted: March 28, 2008
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University:
drainage
irrigation

Additional relevant MeSH terms:
Infection