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2% chlorhexidine gluconate cloths · 1 trial · 2 indications
Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
| Arm | Type | Description |
|---|---|---|
| Control Arm | NO_INTERVENTION | Standard of care pre-operative cleansing with soap and water the night before and morning of surgery |
| Intervention Arm | EXPERIMENTAL | 2% chlorhexidine gluconate cloths the night before and morning of surgery |
| Name | Type | Description |
|---|---|---|
| 2% chlorhexidine gluconate cloths | DRUG | Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths |
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: ...
2% chlorhexidine gluconate cloths are used to prevent surgical site infections, specifically in patients undergoing spine surgery. The cloths are applied to the skin to reduce the risk of post-operative complications related to infection. This use was studied in a Phase 3 clinical trial in the United States.
Sage Therapeutics, Inc. (NASDAQ: SAGE) is the developer of 2% chlorhexidine gluconate cloths for the prevention of surgical site infections. The company conducted a Phase 3 clinical trial to evaluate the product's effectiveness in spine surgery patients.
2% chlorhexidine gluconate cloths are in Phase 3 clinical development for the prevention of surgical site infections. The Phase 3 trial has been completed, and the product remains investigational, meaning it has not yet been approved by regulatory authorities.
2% chlorhexidine gluconate cloths were studied in a single Phase 3 clinical trial, NCT02490631, titled '2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients.' The trial enrolled 158 participants in the United States and has been completed.
2% chlorhexidine gluconate cloths are a specific formulation of chlorhexidine gluconate delivered via pre-moistened cloths for skin preparation. While they contain the same active ingredient as chlorhexidine gluconate solutions, the cloths are designed for topical application to prevent surgical site infections.