A Comparison of Redrubber Versus Penrose Drains

NCT ID: NCT00645957

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-06-30

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

Conditions

Odontogenic Infection

Keywords

drainage; irrigation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

This group will have a red rubber drain(s) placed during surgery. This drain(s) will be irrigated intra and post-operatively

Group Type: ACTIVE_COMPARATOR

red rubber drain

Intervention Type: PROCEDURE

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

1

This group will have a penrose drain(s) placed during surgery to facilitate drainage post-operatively. This drain (s) will not be irrigated.

Group Type: ACTIVE_COMPARATOR

penrose drain

Intervention Type: PROCEDURE

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

Interventions

penrose drain

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

Intervention Type: PROCEDURE

red rubber drain

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age 16 and older

Exclusion Criteria

• none

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00006249

Identifier Type: -

Identifier Source: org_study_id