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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

May 5, 2006
December 18, 2012
March 2006
June 2008   (final data collection date for primary outcome measure)
Post-operative wound infection, after open appendectomy [ Time Frame: 14 to 21 post operative days ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00323453 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Wound Infection Alexis Wound Retractor
Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Appendicitis
Device: Alexis Wound Retractor use in open appendectomy
  • Experimental: wound protection device
    A wound protection device is utilized intraoperatively. Intervention is: Placement of intraoperative device.
    Intervention: Device: Alexis Wound Retractor use in open appendectomy
  • Placebo Comparator: no wound protection
    procedure performed without wound protection device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of appendicitis
  • Open appendectomy
  • Ability to attend follow-up visit
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00323453
06-06
Yes
Kenneth Waxman MD, Santa Barbara Cottage Hospital
Santa Barbara Cottage Hospital
Not Provided
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
Santa Barbara Cottage Hospital
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP