The Effect of Intrawound Vancomycin Powder in Spine Surgery

ConditionSpine Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWindsor-Essex Compassionate Care Community

About this trial

Problem: Postoperative wound infection following various spinal surgeries is a serious complication. The incidence of post-surgical wounds in spine surgery is high, and various researchers have reported different infection rates. In addition, increased healthcare costs, prolonged lengths of stay in hospital, and reduced quality of life as a result of surgical site infections (SSI) are also major concerns. Several methods for avoiding SSI, such as betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder, have been used to reduce the rate of wound infection in spine surgery. Use of local vancomycin has been popular because of its protective effects and lower cost. According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative wound infection rates; however, other studies have revealed a non-significant effect of intra-wound vancomycin use for decreasing the postsurgical wound infection rate.

Solution: Therefore, the investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients requiring surgery due to any spine disease.

Disqualifiers

A previous history of infections at the spine surgical site.

Biopsy procedure.

Patients with a postoperative follow-up time of less than 12 weeks.

Patients allergic to vancomycin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vancomycin

    Drug

    During spinal surgery, participants will receive intrawound vancomycin powder in their wound before closure.

Treatment groups

1,643 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: VancomycinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Infection

Number of patients with post-operative wound infection after spinal surgery (including the type of organism and duration of the procedure). Investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.

Time frame
3 months

Secondary outcomes

1

Complications

Number of patients who developed any complications related to the vancomycin.

Time frame
3 months

Other outcomes

Sponsors and contacts

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