Wound Infection Alexis Wound Retractor

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323453
• Other study ID #: 06-06
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2018
• Source: Santa Barbara Cottage Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of appendicitis

• Open appendectomy

• Ability to attend follow-up visit

Related Conditions & MeSH terms

• Appendicitis
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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