Wound Infection Alexis Wound Retractor

• Sponsor: Santa Barbara Cottage Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00323453
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 4

Study Details

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.

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2006
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Post-operative Wound Infection, After Open Appendectomy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of appendicitis

• Open appendectomy

• Ability to attend follow-up visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105

Sponsors and Collaborators

• Santa Barbara Cottage Hospital

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santa Barbara Cottage Hospital
• ClinicalTrials.gov Identifier: NCT00323453
• Other Study ID Numbers: 06-06
• First Posted: May 9, 2006
• Last Update Posted: Nov 23, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Santa Barbara Cottage Hospital: Appendectomy; Surgery; Infection
• Additional relevant MeSH terms: Infections; Appendicitis; Wound Infection

Study Results

Participant Flow

Arm/Group Title	Experimental Arm	Control Arm
Arm/Group Description	The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure. 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.	Open appendectomy and standardized wound closure 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.
Period Title: Overall Study
STARTED	61	48
COMPLETED	61	48
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Experimental Arm	Control Arm	Total
Arm/Group Description	The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure. 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.	Open appendectomy and standardized wound closure 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.	Total of all reporting groups
Overall Participants	61	48	109
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.4 (18.9)	33.1 (16.1)	34.4 (17.7)
Sex: Female, Male (Count of Participants)
Female	23 37.7%	16 33.3%	39 35.8%
Male	38 62.3%	32 66.7%	70 64.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	61 100%	48 100%	109 100%
Number of Participants with physical barrier to protect the wound (Count of Participants)
Count of Participants [Participants]	61 100%	48 100%	109 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Arm	Control Arm
Arm/Group Description	The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure. 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.	Open appendectomy and standardized wound closure 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.
Measure Participants	61	48
Count of Participants [Participants]	1 1.6%	7 14.6%

Adverse Events

Arm/Group Title	Experimental Arm		Control Arm
Arm/Group Description	The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure. 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.		Open appendectomy and standardized wound closure 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.
All Cause Mortality
	Experimental Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/48 (0%)
Serious Adverse Events
	Experimental Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/61 (1.6%)		7/48 (14.6%)
Skin and subcutaneous tissue disorders
Wound Infection	1/61 (1.6%)	1	7/48 (14.6%)	7
Other (Not Including Serious) Adverse Events
	Experimental Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/48 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.