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NCT07517341
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Conditions: Microbial Contamination, Environmental Contamination
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Bilecik Seyh Edebali Universitesi
Location: Bilecik Şeyh Edebali Üniversitesi Bilecik Merkez
Summary
This randomized controlled study aims to evaluate the effectiveness of a vacuum-assisted electric trimmer (VD-ETM) compared with a standard electric trimmer (ETM) for preoperative hair removal. The study will assess microbial and environmental contamination, surgical site infection (SSI), procedure duration, skin integrity, patient safety, and patient satisfaction. Preoperative hair removal is a critical step in preventing SSI; however, conventional ETM devices may contribute to environmental contamination due to dispersed hair particles. VD-ETM systems are designed to reduce this risk by simultaneously removing hair and capturing particles. This study will provide evidence on whether VD-ETM improves operating room hygiene and patient outcomes.
Eligibility Criteria
Inclusion Criteria:
* Male patients aged 18 years and older
* Scheduled for elective laparoscopic surgery
* Require preoperative hair removal at the surgical site
* Classified as ASA I, ASA II, or ASA III
* Able and willing to provide written informed consent
Exclusion Criteria:
* Female patients
* Patients who do not require preoperative hair removal
* ASA IV or higher risk classification
* Presence of active skin lesions at the surgical site that may affect assessment (e.g., dermatitis, psoriasis, open wounds, prominent scars, recent sunburn)
* Use of any of the following within the last 7 days:
* Antimicrobial soap, lotion, or shampoo
* Topical or systemic antibiotics
* Steroid therapy
* Exposure to biocide-containing pools or thermal/spa waters
* Severe immunosuppression (e.g., absolute neutropenia, high-dose steroid therapy)
* Requirement for emergency surgery
* Known allergy to any products or procedures used in the study
Source: ClinicalTrials.gov (NCT07517341). StuddyBuddy aggregates publicly available trial information.