Trial Outcomes & Findings for Preoperative Jumpstart for Decolonization of P. Acnes (NCT NCT03466658)
NCT ID: NCT03466658
Last Updated: 2020-01-06
Results Overview
The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of the surgery.
TERMINATED
NA
17 participants
7 days post-biopsy
2020-01-06
Participant Flow
Participants were recruited in the Penn State Health Orthopedics Clinic for indications of open or arthroscopic shoulder surgery.
17 participants met inclusion criteria and were enrolled. 3 participants withdrew prior to study intervention.
Unit of analysis: Shoulder
Participant milestones
| Measure |
All Participants
Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder.
|
|---|---|
|
Overall Study
STARTED
|
17 34
|
|
Overall Study
COMPLETED
|
14 28
|
|
Overall Study
NOT COMPLETED
|
3 6
|
Reasons for withdrawal
| Measure |
All Participants
Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Enrolled participants served as their own control, where both shoulders of each participant will be included for the study. The surgical side shoulder will serve as a Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder will serve as a Control Shoulder.
Baseline characteristics by cohort
| Measure |
All Participants
n=17 Participants
Enrolled participants served as their own control. The surgical shoulder served as the Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder served as the Control Shoulder.
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants • Enrolled participants served as their own control, where both shoulders of each participant will be included for the study. The surgical side shoulder will serve as a Treatment Shoulder with the Jumpstart dressing intervention, while the normal non-operative contralateral shoulder will serve as a Control Shoulder.
|
PRIMARY outcome
Timeframe: 7 days post-biopsyPopulation: Data not analyzed due to unexpected culture contamination.
The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of the surgery.
Outcome measures
Outcome data not reported
Adverse Events
JumpStart Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place