Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months

Patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks

Patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent

Patients who agree one more blood withdrawal after operation

Disqualifiers

Patients who agree to accept the spine surgery but do not agree to sign the inform consent

Patients who have allergic reaction to vancomycin

Trial design

Design model

Parallel

Treatments tested in this trial

  • with U-VANCO (vancomycin hydrochloride)

    Drug

    1 gm or 2 gm mixed with autogenous cancellous bone graft

  • without U-VANCO (vancomycin hydrochloride)

    Drug

    no vancomycin added

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Vancomycin (V Group)Experimental treatment 1 intervention
Group B: Without Vancomycin (NV Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame
Post-operative 1 month
2

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame
Post-operative 3 months
3

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame
Post-operative 6 months
4

Bony fusion status

The bony fusion status (Lenke criteria)

Time frame
Post-operative 1 year

Secondary outcomes

1

Vancomycin concentration

Vancomycin concentration was checked for both the serum and drainage.

Time frame
Post-operative days 1
2

Vancomycin concentration

Vancomycin concentration was checked for both the serum and drainage.

Time frame
Post-operative days 3

Other outcomes

Sponsors and contacts

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