NCT00323453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

November 23, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

May 5, 2006

Results QC Date

June 8, 2018

Last Update Submit

November 21, 2018

Conditions

Appendicitis

Keywords

AppendectomySurgeryInfection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

Open appendectomy and standardized wound closure

Procedure: Open appendectomy with standardized wound closure

Interventions

Open appendectomy using Alexis Wound Retractor followed by standardized wound closureDEVICE

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.

Experimental Arm
Open appendectomy with standardized wound closurePROCEDURE

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.

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

AppendicitisInfections

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Limitations and Caveats

This study population included gastric, hepato-biliary-pancreatic, as well as colorectal cases, whereas our study was limited to open appendectomy.

Results Point of Contact

Title
Laura Isaacs (Research Quality Assurance & Integrity Analyst) on behalf of Dr. Kenneth Waxman (PI)
Organization
Santa Barbara Cottage Hospital
lisaacs@sbch.org
805-324-9255

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 23, 2018

Results First Posted

November 23, 2018

Record last verified: 2018-11

Locations

US(1)