---
title: Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains
nct_id: NCT01608854
overall_status: COMPLETED
sponsor: NYU Langone Health
study_type: OBSERVATIONAL
primary_condition: Surgical Wound Infection
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01608854.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01608854"
ct_last_update_post_date: 2016-06-10
last_seen_at: "2026-05-12T06:21:16.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

**Official Title:** Prospective, Randomized Study of the Utilization of Antibiotics and Drains in Spinal Surgery

**NCT ID:** [NCT01608854](https://clinicaltrials.gov/study/NCT01608854)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 539
- **Lead Sponsor:** NYU Langone Health
- **Conditions:** Surgical Wound Infection, Spinal Deformity, Spinal Degeneration
- **Start Date:** 2008-11
- **Completion Date:** 2012-04
- **CT.gov Last Update:** 2016-06-10

## Brief Summary

In spine surgery, postoperative spinal drains are often utilized to prevent fluid buildup around the spinal cord. The purpose of this study is to determine whether postoperative antibiotic treatment continued for the duration of time a drain is in place results in a lower infection rate than antibiotics given for only 24 hours postoperatively.

## Detailed Description

Patients likely to receive postoperative spinal drains were enrolled and randomized preoperatively to receive one of two postoperative antibiotic treatments, either for 24 hours after surgery or for the duration of time the spinal drain was in place. If patients did not receive at least one spinal drain during surgery, they were excluded from the infection analysis and received the institutional standard of 24 hours of postoperative antibiotics. Patients that did receive drains were treated according to their randomization and followed for a minimum of one year for the incidence of surgical site infection. The diagnosis of surgical site infection was determined using the definition provided for the Center for Disease Control (CDC). All patients that developed surgical site infections were treated as appropriate by the attending physician.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Must be scheduled to undergo spine surgery with likely drain placement (3 or more vertebral levels, dependent upon attending surgeon)
* Must be over the age of 18
* Must consent to randomized postoperative antibiotic treatment

Exclusion Criteria:

* Does not receive a drain at the time of surgery
* Surgery is cancelled
* Infection is present at the time of initial surgery
```

## Arms

- **24 Hour Antibiotics** — Patients were randomized to receive 24 hours of postoperative antibiotics following spine surgery
- **Duration Antibiotics** — Patients were randomized to receive antibiotics for the duration of time a spinal drain was in place following spinal surgery

## Interventions

- **Antibiotic Protocol** (OTHER) — Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.

## Primary Outcomes

- **Incidence of Infection** _(time frame: for one year after surgery)_ — Patients were contacted and their medical records were reviewed for a minimum of one year after surgery in order to determine the incidence of postoperative infection. The Center for Disease Control's definition of surgical site infection was applied in determining infection rates.

## Locations (1)

- NYU Hospital for Joint Diseases, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nyu hospital for joint diseases|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01608854.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01608854*  
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