Trial Outcomes & Findings for The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection (NCT NCT03756506)
NCT ID: NCT03756506
Last Updated: 2021-03-30
Results Overview
Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.
COMPLETED
NA
13 participants
10 months
2021-03-30
Participant Flow
dlk
Participant milestones
| Measure |
DuraDerm® Group
All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.
|
Control Group: no DuraDerm
The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DuraDerm® Group
n=6 Participants
All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge.
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.
|
Control Group: no DuraDerm
n=6 Participants
The usual care of pin track sites will be followed as outlined below. All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: Infection rate was analyzed on a per patient and a per pin basis.
Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.
Outcome measures
| Measure |
DuraDerm® Patient Group
n=60 Pins
All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.
|
Patient Control Group: no DuraDerm
n=60 Pins
The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.
|
|---|---|---|
|
Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation
|
0 Pins
|
14 Pins
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: Infection rate was analyzed on a per patient basis.
Research participants identified for the study will be those undergoing Deformity Correction and Traumatic Provisional Fixation who are under the care of the Primary Investigator. These research participants have a number of pins placed to ensure this required rigid fixation. The number of external fixation pins averages approximately ten per research participant. Research participants seen by the Primary Investigator who will be undergoing deformity correction or traumatic provisional fixation, will be invited to take part in this research study. No recruitment of the Principal Investigator's own students, employees, or family members will be allowed. Research participants who do not wish to participate in this randomized study will be provided the standard pin track care protocol this investigator utilizes for his research participants and will not have the opportunity to receive DuraDerm®.
Outcome measures
| Measure |
DuraDerm® Patient Group
n=6 Participants
All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge,tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris. Step 3: Apply DuraDerm® with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. DuraDerm® will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.
|
Patient Control Group: no DuraDerm
n=6 Participants
The usual care of pin track sites will be followed as outlined belowAll pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be performed once daily by hospital nursing staff prior to discharge. Following discharge from the hospital, the pin care protocol will be continued by research participant's caregiver.
Research participants will be instructed to notify the Principal Investigator if they observe any signs or symptoms of infection. These include redness around pin site, discharge, tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills.
Research participants will be instructed that the approach to pin care should occur in a step-wise fashion. Step 1: Brush the pin sites with saline using an ordinary soft toothbrush or gauze with sterile gloves Step 2: If following Step 1, debris remains, use forceps (tweezers) to gently remove debris.
|
|---|---|---|
|
Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation
|
0 Participants
|
2 Participants
|
Adverse Events
DuraDerm® Group
Control Group: no DuraDerm
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