NCT07517341

Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity

An Evaluation of the Effects of Using a Vacuum-Assisted Electric Shaver for Preoperative Hair Removal on Microbial Environmental Contamination and the Skin

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bilecik Seyh Edebali Universitesi · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a randomized controlled trial to evaluate the effectiveness of a vacuum-assisted electric trimmer (VD-ETM) compared with a standard electric trimmer (ETM) for preoperative hair removal. The primary focus is to assess microbial and environmental contamination associated with each method, as well as their impact on surgical site infection (SSI), skin integrity, procedure duration, and patient-related outcomes. Participants will be randomly assigned to the intervention (VD-ETM) or control (ETM) group using block randomization via an online randomization tool. All procedures will be performed preoperatively in the operating room under standardized conditions to ensure consistency between groups. Data collection will include demographic and clinical characteristics, microbial contamination (measured as colony-forming units \[CFU\] from settle plates and skin swab samples), environmental contamination, skin irritation (assessed by visual inspection), and patient satisfaction (evaluated using a structured questionnaire). Swab samples will be collected before and after hair removal, and procedure duration will be recorded. All practitioners will receive standardized training. Surgical site infection (SSI) will be assessed prospectively on postoperative days 7 and 30 through clinical evaluation and, when necessary, structured telephone follow-up. This study is expected to provide evidence-based data to improve preoperative hair removal practices, enhance patient and staff safety, and support evidence-based nursing interventions in surgical care.

Conditions

• Microbial Contamination
• Environmental Contamination

Interventions

Type	Name	Description
DEVICE	Vacuum-Assisted Electric Shaver (VD-ETM) Method	The study population will consist of patients requiring preoperative hair removal at the surgical site. Participants will be randomly assigned into two groups using block randomization: standard electric trimmer (ETM) or vacuum-assisted electric trimmer (VD-ETM). All procedures will be performed preoperatively in the operating room under standardized conditions, using the same boundaries and clipper head type. Data Collection: Data will include demographic and clinical characteristics, microbial contamination (measured by settle plates and sterile swab samples with CFU counts), skin irritation (assessed visually for redness, dryness, and irritation), and patient satisfaction (structured questionnaire). Swab samples will be collected before and after hair removal, environmental contamination will be assessed using petri dishes, and procedure duration will be recorded. All nurses will receive standardized training. Outcome Assessment: Surgical site infection (SSI) will be prospectively

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-11-01
• Completion: 2026-12-30
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Turkey (Türkiye)