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Wound Infection Alexis Wound Retractor - NCT00323453-93105(Clinical Trial 141606)



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City:  Santa Barbara
State:  
CA
Zip Code: 93105
Conditions: Appendicitis
Purpose: 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.
Study summary: 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: Inclusion Criteria: - Clinical diagnosis of appendicitis - Open appendectomy - Ability to attend follow-up visit Exclusion Criteria: - Insulin dependent diabetes
Study is available at: 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
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: ClinicalTrials.gov
Date Processed: March 21, 2011
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