Study Results
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View full resultsBasic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2006-03-31
2008-06-30
Brief Summary
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Detailed Description
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After obtaining informed consent, or informed assent of minors, subjects will be randomized to either of two groups: one groups will undergo a standard open appendectomy using traditional metal retractors. The second group will undergo an open appendectomy with the use of the Alexis® wound retractor.
Pre-operative antibiotic Zosyn will be given prior to skin incision. Skin prep will be betadine, duraprep or gel prep. After entering the peritoneal cavity, the Alexis® retractor will be introduced and used to maintain retraction for the duration of surgery.
In simple appendicitis, the patient will receive one dose of antibiotics six hours after surgery. The patient will not receive oral antibiotics at discharge. In complicated appendicitis, the patient will be given Zosyn until afebrile for 24 hours and a normal white blood cell count. The patient will be discharged on oral antibiotics.
Follow up will occur between the 14th and 21st post operative day. At the test of cure visit, the wound will be checked for erythema, drainage, or opening. It will be assessed whether the subject received any further medical attention or received medications since discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental Arm
The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.
Open appendectomy using Alexis Wound Retractor followed by standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Control Arm
Open appendectomy and standardized wound closure
Open appendectomy with standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Interventions
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Open appendectomy using Alexis Wound Retractor followed by standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Open appendectomy with standardized wound closure
The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Eligibility Criteria
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Inclusion Criteria
* Open appendectomy
* Ability to attend follow-up visit
18 Years
ALL
No
Sponsors
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Santa Barbara Cottage Hospital
OTHER
Responsible Party
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Principal Investigators
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Kenneth Waxman, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Barbara Cottage Hospital Director of Surgical Education
Todd Pederson, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Barbara Cottage Hospital/Naval Hospital
Benedict Taylor, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Barbara Cottage Hospital Surgical Resident
Pamela Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Barbara Cottage Hospital
Locations
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Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Countries
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Other Identifiers
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06-06
Identifier Type: -
Identifier Source: org_study_id
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