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The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds
The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds were irrigated with normal saline solution thorough a bulb syringe. In both subgroup specimens for bacterial culture were harvested by swabs from surgical site before and after irrigation of the wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Pulsed PVP-I Irrigation | Experimental | Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with Povidone-Iodine (PVP-I) diluted to a 3% concentration (30g/l) in 2 l of saline performed before applying the bone graft |
|
| Group B - Pulsed Saline Irrigation | Active Comparator | Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with only 2 litres of saline solution (without povidone Iodine) performed before applying the bone graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A - Pulsed PVP-I Irrigation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With surgical site infection | Comparison of the results obtained from microbiological bacterial cultures of samples harvested during complex spine surgery in two groups of patients treated intraoperatively with pulsatile irrigation with diluted PVP-I (group A) or pulsatile irrigation with saline solution (group B) | From the surgery to 1 year after |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20407344 | Background | Schuster JM, Rechtine G, Norvell DC, Dettori JR. The influence of perioperative risk factors and therapeutic interventions on infection rates after spine surgery: a systematic review. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S125-37. doi: 10.1097/BRS.0b013e3181d8342c. | |
| 11743489 | Background | National Nosocomial Infections Surveillance (NNIS) System Report, Data Summary from January 1992-June 2001, issued August 2001. Am J Infect Control. 2001 Dec;29(6):404-21. doi: 10.1067/mic.2001.119952. No abstract available. |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D013124 | Spinal Injuries |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
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| D007239 |
| Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |