Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery (POL)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Orthopedic Surgery

Treatments: Drug: 2% CHX cloths

Study type: Interventional

Funder types: Other

Identifiers

NCT05120739

38RC19.254

Details and patient eligibility

About

Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients,
• undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
• admitted the day before the operation
• and having given their written consent.

Exclusion criteria

• presence of a documented infection at the time of the intervention,
• presence of skin wounds,
• presence of antibiotic treatment within 15 days before the operation
• intolerance to CHX,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

Interventional

Experimental group

Description:

Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths

Treatment:

Drug: 2% CHX cloths

Control

No Intervention group

Description:

Skin preparations (the day before and the morning of the operation) with the 4% CHX soap (standard of care)