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Wound Infection Alexis Wound Retractor

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open appendectomy using Alexis Wound Retractor followed by standardized wound closure
Open appendectomy with standardized wound closure
Sponsored by
Santa Barbara Cottage Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Appendectomy, Surgery, Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of appendicitis Open appendectomy Ability to attend follow-up visit

Sites / Locations

  • Santa Barbara Cottage Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Arm

Control Arm

Arm Description

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

Open appendectomy and standardized wound closure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2006
Last Updated
November 21, 2018
Sponsor
Santa Barbara Cottage Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00323453
Brief Title
Wound Infection Alexis Wound Retractor
Official Title
Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Barbara Cottage Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendectomy, Surgery, Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Open appendectomy and standardized wound closure
Intervention Type
Device
Intervention Name(s)
Open appendectomy using Alexis Wound Retractor followed by standardized wound closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open appendectomy with standardized wound closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative Wound Infection, After Open Appendectomy
Description
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.
Time Frame
21 post operative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of appendicitis Open appendectomy Ability to attend follow-up visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Waxman, MD
Organizational Affiliation
Santa Barbara Cottage Hospital Director of Surgical Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Todd Pederson, MD
Organizational Affiliation
Santa Barbara Cottage Hospital/Naval Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benedict Taylor, MD
Organizational Affiliation
Santa Barbara Cottage Hospital Surgical Resident
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela Lee, MD
Organizational Affiliation
Santa Barbara Cottage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States

12. IPD Sharing Statement

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Wound Infection Alexis Wound Retractor

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