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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Device: Open appendectomy using Alexis Wound Retractor followed by standardized wound closure; Procedure: Open appendectomy with standardized wound closure

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.	Device: Open appendectomy using Alexis Wound Retractor followed by standardized wound closure; The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.
Placebo Comparator: Control Arm; Open appendectomy and standardized wound closure	Procedure: Open appendectomy with standardized wound closure; The control arm subjects will undergo open appendectomy and standardized wound closure. The experimental arm will undergo open appendectomy utilizing the Alexis® retractor, followed by standardized wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Wound Infection, After Open Appendectomy	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.	21 post operative days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 9, 2006

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Infection; Surgery; Appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Infections; Appendicitis; Wound Infection
• Other Study ID Numbers: 06-06