An interventional study of Saline Solution and Soap solution in Open Fracture Wounds, sponsored by Prisma Health-Upstate. Completed at 31 sites in 5 countries. Open to participants aged 14 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-11.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment
Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's enrollment of 2,540 is above the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →Prisma Health-Upstate is the lead sponsor of 76 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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The human immunodeficiency virus, which weakens the immune system.
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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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Saline Solution · Procedure: Gravity Flow Irrigation
Procedure: Saline Solution · Procedure: Low Pressure Irrigation
Procedure: Saline Solution · Procedure: High Pressure
Procedure: Soap solution · Procedure: Gravity Flow Irrigation
Procedure: Soap solution · Procedure: Low Pressure Irrigation
Procedure: Soap solution · Procedure: High Pressure
Irrigation with Saline
Irrigation with Castile Soap Solution (80 ml per 3L bag of saline)
Gravity flow irrigation will be standardized across participating centers as 3L bags of normal saline (alone or with soap solution) suspended 6-8 feet above floor level using an I.V. pole. Irrigation tubing (measuring 1/4 - 3/8 inch inner diameter) will be connected to the 3L bag and secured with a stopcock (or compressive device) until ready for use.
Irrigation with the Stryker SurgiLav System. At the low pressure setting delivers 5.9 p.s.i. pressure. The high-flow irrigator tip will be held perpendicular to and 5cm above the wound. Irrigation with the Zimmer PulsaVac. For low pressure delivery, the shower tip will be used at the low pressure setting which delivers a pressure of 5.8 p.s.i.
Irrigation with the Stryker SurgiLav System. For the high pressure delivery, the multi-orifice tip will be used at the high setting which delivers a pressure of 30 p.s.i. Irrigation with the Zimmer PulsaVac System: For the high pressure delivery the shower tip will be used at the high pressure setting which delivers a pressure of 23 p.s.i.
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
Time frame: within 12 months
Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D
Time frame: 12 months
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Prisma Health-Upstate