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OpenTrials
Completed

NCT Number: NCT00645957

A Comparison of Redrubber Versus Penrose Drains

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 16 and older

Exclusion criteria

  • none

Treatment and study plan

penrose drain

Procedure

incision and drainage of the infection with placement of a penrose drain

red rubber drain

Procedure

incision and drainage of infection and placement of a red rubber drain

Primary outcomes

  1. Resolution of infection

    Time frame: several days

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

A Comparison of Redrubber Versus Penrose Drains in the Management of Odontogenic (Dental) Infections

Acronym: redrubber

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 28, 2008
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.