Clinical trial NCT00323453: Wound Infection Alexis Wound Retractor
Official title: Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendectomy
Surgery
Infection
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Post-operative Wound Infection, After Open Appendectomy
timeFrame: 21 post operative days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
affiliation: Santa Barbara Cottage Hospital Director of Surgical Education
name: Kenneth Waxman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Barbara Cottage Hospital/Naval Hospital
name: Todd Pederson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Barbara Cottage Hospital Surgical Resident
name: Benedict Taylor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Barbara Cottage Hospital
name: Pamela Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: