Effect of Standard Normothermia Protocol On Surgical Site Infections
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|ClinicalTrials.gov Identifier: NCT02961244|
Recruitment Status : Completed
First Posted : November 10, 2016
Results First Posted : May 11, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets. Device: Forced Air Warming blanket||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||June 2016|
No Intervention: Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Active Comparator: Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Device: Forced Air Warming blanket
- Surgical Site Infection Rate [ Time Frame: Postoperative 30 days ]
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.
All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" .
With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )
- Maintaining Normothermia Rate [ Time Frame: Surgery day ]
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed.
With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961244
|Study Director:||Mustafa Cem Terzi, Proffessor Doctor||Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department|