Wound Infection Alexis Wound Retractor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Waxman MD, Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier:
NCT00323453
First received: May 5, 2006
Last updated: December 18, 2012
Last verified: May 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Enrollment: 119
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of appendicitis
  • Open appendectomy
  • Ability to attend follow-up visit
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00323453

Locations
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
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
Principal Investigator: Pamela Lee, MD Santa Barbara Cottage Hospital
  More Information

No publications provided

Responsible Party: Kenneth Waxman MD, Director of Surgical Education, Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT00323453     History of Changes
Other Study ID Numbers: 06-06
Study First Received: May 5, 2006
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Santa Barbara Cottage Hospital:
Appendectomy
Surgery
Infection

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

ClinicalTrials.gov processed this record on August 26, 2014