Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBilecik Seyh Edebali Universitesi
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Vacuum-Assisted Electric Shaver (VD-ETM) Method
DeviceThe 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: müdahale koluExperimental treatment 1 intervention
Group B: kontrol grubuNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Microbial Environmental Contamination
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)
Time frame
Time Frame: Immediately after completion of the hair removal procedureSponsors and contacts
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Source ClinicalTrials.gov
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