Wound Infection Alexis Wound Retractor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323453
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):
Kenneth Waxman MD, Santa Barbara Cottage Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Appendicitis Device: Alexis Wound Retractor use in open appendectomy Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor
Study Start Date : March 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: wound protection device
A wound protection device is utilized intraoperatively. Intervention is: Placement of intraoperative device.
Device: Alexis Wound Retractor use in open appendectomy
Placebo Comparator: no wound protection
procedure performed without wound protection device

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323453

United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Santa Barbara Cottage Hospital
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
Principal Investigator: Pamela Lee, MD Santa Barbara Cottage Hospital

Responsible Party: Kenneth Waxman MD, Director of Surgical Education, Santa Barbara Cottage Hospital Identifier: NCT00323453     History of Changes
Other Study ID Numbers: 06-06
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: May 2009

Keywords provided by Kenneth Waxman MD, Santa Barbara Cottage Hospital:

Additional relevant MeSH terms:
Wound Infection
Surgical Wound Infection
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Postoperative Complications
Pathologic Processes