“The effect of duration of wound drainage on allogeneic blood transfusions using a postoperative retransfusion system after major orthopaedic surgery.”

Rationale:

Use of post operative wound drains in hip and knee arthroplasty is still debated. Drainage is said to reduce wound haematoma, improves wound healing and prevents infection. Therefore many patients are treated with wound drainage until the first postoperative day. However, it is also said that continual drainage after surgery will increase the amount of shed blood because the counteraction of haematoma formation will not take place. In addition, drains may act as access route for bacterial contamination of the wound which can cause a periprosthetic infection. This favours no drainage at all. These assumptions are based on results in patients where a drain was used as a drainage system only. However, retransfusion drainage systems after arthroplasty are gaining popularity. These retransfusion systems are used to reduce the need for allogeneic blood transfusions. It is interesting if the potential benefits outweigh the controversial thoughts in drainage. Therefore we want to evaluate whether drainage, using a retransfusion system, after major arthroplasty is useful at all.



Objective:

Is the use of postoperative autologous retransfusion drainage (ARD) systems useful in hip and knee arthroplasty.



Study design:

After inclusion, patients are randomised into three groups. Group 1: no drainage, group 2: drainage for 6 hours after surgery and group 3: drainage for 24 hours after surgery. Randomisation with sealed envelopes (stratification per clinic) will be done at the end of surgery just before wound closure. Shed blood in group 2 and 3 is collected and retransfused 6 hours after surgery. After retransfusion the drain is removed in group 2 whereas the drain is continued for drainage until drain removal the first postoperative morning.



Study population:

570 patients planned to undergo primary total hip and knee arthroplasty fulfilling the in- and exclusion criteria will enter this study after given written informed consent.



Intervention:

An existing intervention will be investigated, autologous retransfusion drainage with the Bellovac® ABT retransfusion system.



Main study parameters/endpoints:

The primary endpoint is the amount of allogeneic blood transfusions in the three groups. Allogeneic blood transfusions are given by specific haemoglobin levels. Secondary endpoints are haemoglobin levels in the perioperative period, and complications with special focus on wound healing disturbances after surgery. Furthermore, all clinical data will be collected such as length of hospitalisation, co morbidity and others.



Nature and extent of the burden and risks associated with participation benefit and group relatedness:

There are no potential risks or benefits related to participation in this study.

A postoperative retransfusion system is most effective in terms of allogeneic blood transfusion rates when in situ for maximum of 6 hours after major orthopaedic surgery.

1. Pre-operative;

2. Day 1;

3. Day 3;

4. 6 weeks.

Autologous retransfusion drainage with the Bellovac® ABT retransfusion system.



After inclusion, patients are randomised into three groups:

1. Group 1: No drainage;

2. Group 2: Drainage for 6 hours after surgery;

3. Group 3: Drainage for 24 hours after surgery.

Randomisation with sealed envelopes (stratification per clinic) will be done at the end of surgery just before wound closure. Shed blood in group 2 and 3 is collected and retransfused 6 hours after surgery. After retransfusion the drain is removed in group 2 whereas the drain is continued for drainage until drain removal the first postoperative morning.