An interventional study of Drainage of surgical wound in Osteoarthritis, Knee, sponsored by Hospital Beatriz Ângelo. Status unknown at 1 site in Portugal. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by Hospital Beatriz Ângelo · Not applicable, Interventional, and Treatment
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery
All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).
Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.
Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.
In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.
A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).
In all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.
A standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.
Hidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.
The normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 42 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Hospital Beatriz Ângelo is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who received a drain during surgery
Procedure: Drainage of surgical wound
Participants who did not receive a drain during surgery
Introduction of a drain before full fascial closure
Total RBC loss
Total red blood cells loss after surgery
Time frame: 96 hours
Total RBC loss
Total red blood cells loss after surgery
Time frame: 24 hours
Total RBC loss
Total red blood cells loss after surgery
Time frame: 1 hour
Blood transfusion requirements
Blood transfusions requirements
Time frame: 96 hours
Knee Society Score score
Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)
Time frame: 14 days
Haematocrit level
Haematocrit level
Time frame: 1 hour
Haematocrit level
Haematocrit level
Time frame: 24 hours
Haematocrit level
Haematocrit level
Time frame: 96 hours
Haemoglobin level
Haemoglobin level
Time frame: 1 hour
Haemoglobin level
Haemoglobin level
Time frame: 24 hours
Haemoglobin level
Haemoglobin level
Time frame: 96 hours
Surgery duration
Surgery duration (min)
Time frame: 0hour
Length of skin incision
Length of skin incision
Time frame: 0 hour
Tourniquet duration
Tourniquet duration (min)
Time frame: 0 hour
Surgical blood loss
Surgical blood loss (mL)
Time frame: 0 hour
Iron
Iron products used
Time frame: 96 hours
Transfusion reactions
Transfusion reactions
Time frame: 96 hours
Drain volume
Drain volume (mL)
Time frame: 24 hours
MKC
Midpatellar Knee Circumference (cm)
Time frame: 48 hours
MKC
Midpatellar Knee Circumference (cm)
Time frame: 96 hours
MKC
Midpatellar Knee Circumference (cm)
Time frame: 14 days
ROM
Range of motion (°)
Time frame: 48 hours
ROM
Range of motion (°)
Time frame: 96 hours
ROM
Range of motion (°)
Time frame: 14 days
Fluidotherapy excess
Fluidotherapy excess (mL)
Time frame: 96 hours
Wound complications (i. e., wound dehiscence, infection)
Wound complications (i. e., wound dehiscence, infection)
Time frame: 14 days
Lower leg deep vein thrombosis
Lower leg deep vein thrombosis
Time frame: 14 days
Plan to share: No
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Hospital Beatriz Ângelo