Wound Infection 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.
Device: Alexis Wound Retractor use in open appendectomy
|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|
- Post-operative wound infection, after open appendectomy [ Time Frame: 14 to 21 post operative days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323453
|United States, California|
|Santa Barbara Cottage Hospital|
|Santa Barbara, California, United States, 93105|
|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|