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NCT Number: NCT07517341

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bilecik Şeyh Edebali Üniversitesi

Bilecik, Merkez, 11100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Vacuum-Assisted Electric Shaver (VD-ETM) Method

Device

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

Primary outcomes

  1. Microbial Environmental Contamination

    Time frame: Time Frame: Immediately after completion of the hair removal procedure

    Description:

    Environmental contamination will be measured using settle plates (Petri dishes containing culture medium) placed at standardized distances during preoperative hair removal. Plates will be exposed for 5-10 minutes, incubated at 37 °C for 24-72 hours, and colony-forming units (CFU) will be counted. Additional microbial contamination will be assessed using sterile swab samples collected from a standardized surface area (25×25 cm) before and after hair removal and cultured on agar plates. Measurement Unit: Colony-forming units (CFU/plate and CFU/cm²)

Study contacts

Contact information is provided by the study sponsor or research team.

Esma AYDIN

CONTACT

[email protected]

+905316901620

Sponsors and collaborators

Lead sponsor

Bilecik Seyh Edebali Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

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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