Hvidovre University Hospital
Hvidovre, Denmark
NCT Number: NCT02427711
To investigate if the use of a bipolar sealer for skin and capsula incision results in decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hvidovre, Denmark
In patients undergoing primary total knee arthroplasty, perioperative anemia is highly prevalent. In a systematic review, preoperative anemia was found in 24 +/- 9% and postoperative anemia in 51% +/- 10%. Perioperative anemia was associated with a blood transfusion rate of 45 +/- 25%, postoperative infections, poorer physical functioning and recovery, and increased length of hospital stay (LOS) and mortality. Although the best transfusion trigger in elective patients remains unknown, restrictive transfusion protocols are recommended and avoidance of blood transfusion if possible.
The only non-systemic modality capable of reducing blood loss before it occurs is a bipolar sealer (Aquamantys). By pre-incisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced without tissue charring.
Previously studies on the use of Aquamantys in primary knee arthroplasty have had various outcomes, the most recent being negative while the former 3 were positive regarding reduction in blood loss, drop in hgb and transfusions. No published date exist on potential outcomes in revision knee arthroplasty where blood loss and transfusion needs exceeds that of primary total knee arthroplasty by far. Aquamantys hence would theoretically benefit the most in a revision setting without the use of a tourniquet - and would be an interesting modality in modern contemporary fast-track revision if shown effective despite/on top of the use of additional blood saving modalities. The present study is therefore motivated by investigating this aspect.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Other names: Aquamantys
Time frame: 2nd postoperative morning
Time frame: 1st. postoperative morning
Time frame: while hospitalized expected 5 days.
Time frame: 90 days after surgery
Hvidovre University Hospital
Other
Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer - A Prospective Cohort Study With Retrospective Controls
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