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Clinical Trials/NCT00323453
NCT00323453CompletedNot Applicable

Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor

Santa Barbara Cottage Hospital1 site in 1 country109 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
109
Locations
1
Primary Endpoint
Post-operative Wound Infection, After Open Appendectomy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Experimental Arm

Experimental

The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.

Intervention: Open appendectomy using Alexis Wound Retractor followed by standardized wound closure (Device)

Control Arm

Placebo Comparator

Open appendectomy and standardized wound closure

Intervention: Open appendectomy with standardized wound closure (Procedure)

Outcomes

Primary Outcomes

Post-operative Wound Infection, After Open Appendectomy

Time Frame: 21 post operative days

Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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