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Completed

NCT Number: NCT00323453

Wound Infection 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Open appendectomy using Alexis Wound Retractor followed by standardized wound closure

Device

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.

Open appendectomy with standardized wound closure

Procedure

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Santa Barbara Cottage Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 9, 2006
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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