An interventional study of 75 mmHg suction and 125 mmHg in Fractures, Closed, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-07.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study.
The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound. BMP-2 is a protein used by the body to increase bone healing, decrease the need for additional surgery, and reduce infection rates.
The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours depending on amount of drainage. The IVAC by itself helps reduce wound swelling and complications (such as infection).
It is hypothesized that the negative pressure associated with an IVAC is not sufficient to remove BMP-2 from a surgical wound.
BMP-2 is commonly used in open tibia fractures at the time of definitive wound closure, and these wounds are prone to increased swelling and wound complications. The recent observation that IVAC decreases wound edema and increases oxygenation has led to their use in such cases. Used in conjunction, it is entirely possible that the negative pressure exerted by the IVAC can remove BMP-2 from surgical site and therefore decreases the effectiveness of BMP-2. We seek to determine if BMP-2 is present in effluent from the IVAC. If in this study the hypothesis is found to be wrong, and BMP-2 is found within the IVAC effluent, we are prepared to proceed with a follow-up study to quantify the BMP-2 removed by the IVAC.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IVAC suction 75 mmHg
Other: 75 mmHg suction
IVAC suction 125 mmHg
Other: 125 mmHg
Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.
Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Presence of BMP-2 in Effluent Collected in IVAC Canister
Presence of BMP-2 in effluent collected in IVAC canister
Time frame: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application
| Milestone | 75 mmHg | 125 mmHg |
|---|---|---|
| Started | 8 | 12 |
| Completed | 4 | 8 |
| Not completed | 4 | 4 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 3 | 4 |
Presence of BMP-2 in effluent collected in IVAC canister
| participants | 75 mmHg | 125 mmHg |
|---|---|---|
| Presence of BMP-2 in Effluent Collected in IVAC Canister | 6 | 11 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 75 mmHg | — | 1/8 (12.5%) | 1/8 (12.5%) |
| 125 mmHg | — | 1/12 (8.3%) | 0/12 (0%) |
| Event | 75 mmHg | 125 mmHg |
|---|---|---|
| died secondary to chronic renal failureRenal and urinary disorders | 1/8 | 0/12 |
| wound infectionInfections and infestations | 1/8 | 1/12 |
| pulmonary embolisRespiratory, thoracic and mediastinal disorders | 0/8 | 1/12 |
| nonunionMusculoskeletal and connective tissue disorders | 0/8 | 1/12 |
| Event | 75 mmHg | 125 mmHg |
|---|---|---|
| delayed unionMusculoskeletal and connective tissue disorders | 1/8 | 0/12 |
| Age, Continuous(years) | 75 mmHg | 125 mmHg | Total |
|---|---|---|---|
| Mean | 45 ± 17.5 | 42.1 ± 16.6 | 43 ± 17 |
| Sex: Female, Male(Participants) | 75 mmHg | 125 mmHg | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 5 | 9 | 14 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Dec 2008, a primary completion of May 2012 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 1 year 9 months after primary completion.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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