Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cheng-Kung University Hospital

About this trial

This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who were diagnosed with lumbar spinal stenosis need to undergo posterior lumbar decompression with fusion surgery.

Disqualifiers

People who are allergic to disinfectants (Providine or CHG)

The surgical site has been operated before.

Patients under active infection status.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Povidone-iodine solution; chlorhexidine gluconate

    Drug

    Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: control groupPlacebo comparator 1 intervention
Group B: povidone-iodine groupExperimental treatment 1 intervention
Group C: CHG groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bacteria culture and Polymerase chain reaction exam

Samples from deep and superficial tissues and implants will be taken for bacterial culture and PCR analysis. Positive means bacterial growth.

Time frame
one week postoperatively.

Secondary outcomes

1

Post operative infection

Patient develops symptomatic wound infection will be recorded

Time frame
within 6 months after surgery

Other outcomes

Sponsors and contacts

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