Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Wound Infection Alexis Wound Retractor
This study is currently recruiting participants.
Verified by Santa Barbara Cottage Hospital, April 2007
Sponsored by: Santa Barbara Cottage Hospital
Information provided by: Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT00323453
  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.


Condition Intervention Phase
Appendicitis
Device: Alexis Wound Retractor use in open appendectomy
Phase IV

MedlinePlus related topics: Appendicitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor

Further study details as provided by Santa Barbara Cottage Hospital:

Primary Outcome Measures:
  • Post-operative wound infection, after open appendectomy [ Time Frame: 14 to 21 post operative days ]

Estimated Enrollment: 300
Study Start Date: March 2006
Estimated Study Completion Date: April 2009
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of appendicitis
  • Open appendectomy
  • Ability to attend follow-up visit

Exclusion Criteria:

  • Insulin dependent diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323453

Contacts
Contact: Kenneth Waxman, MD 805-569-7316 kwaxman@sbch.org

Locations
United States, California
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Kenneth Waxman, MD     805-569-7316     kwaxman@sbch.org    
Sponsors and Collaborators
Santa Barbara Cottage Hospital
Investigators
Principal Investigator: Kenneth Waxman, MD Santa Barbara Cottage Hospital Director of Surgical Education
Principal Investigator: Todd Pederson, MD Santa Barbara Cottage Hospital/Naval Hospital
Principal Investigator: Benedict Taylor, MD Santa Barbara Cottage Hospital Surgical Resident
  More Information

Study ID Numbers: 06-06
Study First Received: May 5, 2006
Last Updated: May 1, 2007
ClinicalTrials.gov Identifier: NCT00323453  
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by Santa Barbara Cottage Hospital:
Appendectomy
Surgery
Infection

Study placed in the following topic categories:
Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases
Appendicitis
Wounds and Injuries
Disorders of Environmental Origin
Surgical Wound Infection
Intestinal Diseases
Gastroenteritis
Wound Infection

Additional relevant MeSH terms:
Pathologic Processes
Infection
Cecal Diseases

ClinicalTrials.gov processed this record on January 14, 2009