Trial Outcomes & Findings for Wound Infection Alexis Wound Retractor (NCT NCT00323453)
NCT ID: NCT00323453
Last Updated: 2018-11-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
21 post operative days
Results posted on
2018-11-23
Participant Flow
Participant milestones
| Measure |
Experimental Arm
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.
|
Control Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
48
|
|
Overall Study
COMPLETED
|
61
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=61 Participants
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.
|
Control Arm
n=48 Participants
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
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 18.9 • n=61 Participants
|
33.1 years
STANDARD_DEVIATION 16.1 • n=48 Participants
|
34.4 years
STANDARD_DEVIATION 17.7 • n=109 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=61 Participants
|
16 Participants
n=48 Participants
|
39 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=61 Participants
|
32 Participants
n=48 Participants
|
70 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
61 participants
n=61 Participants
|
48 participants
n=48 Participants
|
109 participants
n=109 Participants
|
|
Number of Participants with physical barrier to protect the wound
|
61 Participants
n=61 Participants
|
48 Participants
n=48 Participants
|
109 Participants
n=109 Participants
|
PRIMARY outcome
Timeframe: 21 post operative daysWound 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.
Outcome measures
| Measure |
Experimental Arm
n=61 Participants
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.
|
Control Arm
n=48 Participants
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.
|
|---|---|---|
|
Post-operative Wound Infection, After Open Appendectomy
|
1 Participants
|
7 Participants
|
Adverse Events
Experimental Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=61 participants at risk
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.
|
Control Arm
n=48 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
1.6%
1/61 • Number of events 1
|
14.6%
7/48 • Number of events 7
|
Other adverse events
Adverse event data not reported
Additional Information
Laura Isaacs (Research Quality Assurance & Integrity Analyst) on behalf of Dr. Kenneth Waxman (PI)
Santa Barbara Cottage Hospital
Phone: 805-324-9255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place