Intraosseous Antibiotics for Osseointegration
ConditionOsseointegration Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
The purpose of this research study is to learn about the characteristics of infection in osseointegration patients. This research study will also study how safe and effective it is to use antibiotics inside the bone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection
>18 years of age
Disqualifiers
Unable to follow up at site for 1 year
Patients that speak neither English nor Spanish
<18 years of age
Trial design
Design model
Single group
Treatments tested in this trial
intraosseous antibiotic delivery
Procedure/SurgeryAfter debridement, patients will receive intraosseous (IO) vancomycin 500mg in 150ml of normal saline during surgery. The solution will be prepared by the hospital pharmacy and administered via an IO cannula. The cannula will be placed proximal to the intramedullary fixture. In cases where a tourniquet can be utilized proximal to the IO cannula, the antibiotic is delivered as a bolus. Tourniquet must be up for 1 hour after installation of the IO cases where the residual limb is too short to allow tourniquet (pneumatic or elastic) proximal to the IO cannula, the intraosseous antibiotic must be infused at a rate not to exceed 10mg/min or less. This can be accomplished by connecting intravenous tubing to the antibiotic mixture and the IO cannula. In cases without a tourniquet, IO infusion should begin during the irrigation phase and continue through the complete closure of the wound, since it requires a significant amount of time 50-60 min.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ObservationalNo intervention 0 interventions
Group B: Intraosseous Antibiotics for OsseointegrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Patients Who Develop Wound Dehiscence
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Time frame
Week 22
Number of Patients Who Develop Wound Dehiscence
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Time frame
Week 63
Number of Patients Who Develop Wound Dehiscence
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Time frame
Month 34
Number of Patients Who Develop Wound Dehiscence
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Time frame
Month 6Secondary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS -29)
The PROMIS-29 is a free to use, publicly available generic health related quality of life measure that includes seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. A 5-point Likert scale is used for each question and norm-based total scores (range 0-100) have been calculated so that 50 represents the mean and one standard deviation is 10 points. Higher scores represent better function.
Time frame
2-weeks, 6-weeks, 3-months, 6-months, 12-months2
Veterans RAND 12 (VR-12) Health Survey - Physical Component Score
The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Physical Component Score. The mean score is 50 with a standard deviation of 10. Higher scores indicate better average health (higher than 50 means better than average health, below 50 means below average health).
Time frame
2-weeks, 6-weeks, 3-months, 6-months, 12-months3
Veterans Rand 12 (VR12) Health Survey - Mental Component Score
The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Mental Component Score. The mean score is 50 with a standard deviation of 10. Higher scores indicate better average health (higher than 50 means better than average health, below 50 means below average health).
Time frame
2 weeks, 6-weeks, 3-months, 6-months, 12-months4
Pain - Numeric Rating Scale
A scale from 0-10, where 0 is no pain and 10 is the worst pain.
Time frame
2-weeks, 6-weeks, 3-months, 6-months, 12-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: