Wound Infection Alexis Wound Retractor - NCT00323453-93105 (Clinical Trial 141606)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy141606.aspx
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| City: |
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Santa Barbara |
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State:
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CA |
| Zip Code: |
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93105 |
| Conditions: |
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Appendicitis |
| Purpose: |
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The purpose of this study is to determine whether the incidence of surgical site wound
infection will be reduced in open appendectomy patients through the use of the Alexis® wound
retractor.
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| Study summary: |
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Aim: This is a randomized comparison of open appendectomy using metal retractors and open
appendectomy using the Alexis® wound retractor in patients with simple and complicated
appendicitis. The study is designed in order to minimize bias by standardizing the two
procedures and blinding patients and nurses during the preoperative and postoperative
period.
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. |
| Criteria: |
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Inclusion Criteria:
- Clinical diagnosis of appendicitis
- Open appendectomy
- Ability to attend follow-up visit
Exclusion Criteria:
- Insulin dependent diabetes |
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| Study is available at: |
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Santa Barbara Cottage Hospital
Santa Barbara, CA 93105
United States
Primary Contact:
Kenneth Waxman, MD
Email: kwaxman@sbch.org
Phone: 805-569-7316
Secondary Contact:
Kenneth Waxman, MD
Email: kwaxman@sbch.org
Phone: 805-569-7316 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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