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Completed

NCT Number: NCT02490631

2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients

Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients.

Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).

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Key information

Conditions

Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Complication Postoperative Complications Surgical Wound Infection Wound Infection

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and approached for interest, if consenting process completed, patients will be randomized to one of 2 arms in 1:1 through a block randomization table.

Those enrolled into the study arm will receive the CHG cloths and instructions for use from research personal. Those randomized to the control arm will receive standard of care skin cleansing by nursing staff.

All subjects who have signed consent will have a skin swab culture taken the day of screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended incision line. The investigators will also obtain skin swab cultures at site of incision preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day follow up.

Both groups will be evaluated daily by study personnel for the development of SSI until post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a daily high definition picture will be taken of the incision line to further document signs of SSI development (pictures will not have any patient identifiable information). Additional evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators utilizing the CDC guideline will grade the incision line for presence of SSI. Measured change in skin flora will be performed by comparing skin swab cultures of intervention group versus standard of care group and individual changes pre and post operatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:

  • Diabetic OR
  • BMI>30 OR
  • ASA>2 OR
  • pre-operatively hospitalized OR
  • >60 years old OR
  • chronic steroids/immunosuppressive medications OR
  • prior history of SSI

Exclusion criteria

  • Unable to consent
  • Non English speaking
  • Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
  • Current infection or history of spine infections
  • Patients with tumors or intradural spinal pathology.

Treatment and study plan

2% chlorhexidine gluconate cloths

Drug

Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths

Other names: SAGE patient preoperative skin preparation cloths

Primary outcomes

  1. Participants With Surgical Site Infection Development at 30 Days Post-operative

    Time frame: post op day 30

    Evaluation daily using the CDC guidelines, daily measurements and deidentified photos

Secondary outcomes

  1. Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op

    Time frame: Day of Surgery, Day of Discharge, 30 days post-op

    Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Sage Products, Inc.

Registry information

Official study title

A Randomized Controlled Trial of 2% Chlorhexidine Gluconate Skin Preparation Cloths for the Prevention of Post op Surgical Site Infections in Spine Patients (Decrease SSI or DeSSI)

Acronym: DeSSI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2015
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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