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Wound Infection Alexis Wound Retractor

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ClinicalTrials.gov Identifier: NCT00323453
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Santa Barbara Cottage Hospital

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.

Condition or disease Intervention/treatment Phase
Appendicitis Device: Open appendectomy using Alexis Wound Retractor followed by standardized wound closure Procedure: Open appendectomy with standardized wound closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor
Study Start Date : March 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323453


Locations
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United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Santa Barbara Cottage Hospital
Investigators
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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

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Responsible Party: Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT00323453    
Other Study ID Numbers: 06-06
First Posted: May 9, 2006    Key Record Dates
Results First Posted: November 23, 2018
Last Update Posted: November 23, 2018
Last Verified: November 2018
Keywords provided by Santa Barbara Cottage Hospital:
Appendectomy
Surgery
Infection
Additional relevant MeSH terms:
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Infection
Appendicitis
Wound Infection
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases