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

NCT07517341 | Not Yet Recruiting DMC

• 1 other identifier: BilecikSeyhEU-CHH-EA-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Environmental Contamination; Microbial Contamination

Keywords

Vacuum-assisted electric hair removal system; Surgical site infection; Hair removal; Microbial contamination; Skin integrity

Outcome Measures

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: Immediately after completion of the hair removal procedure

Study Arms (2)

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EXPERIMENTAL

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

Device: Vacuum-Assisted Electric Shaver (VD-ETM) Method

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NO INTERVENTION

No interventions will be performed on the control group by the researcher; the institution's standard protocol will be followed.

Interventions

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

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Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients will be included in this study because preoperative hair removal at the surgical site is more commonly required and routinely performed in male patients due to higher hair density and distribution. Including only male participants ensures standardization of the intervention, reduces variability related to hair characteristics, and allows for more accurate comparison of the two hair removal methods (VD-ETM vs. standard ETM).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Şeyh Edebali Üniversitesi

Bilecik, Merkez, 11100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Methods

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dilek AYGİN

  Sakarya University

  STUDY DIRECTOR

Central Study Contacts

Esma AYDIN

CONTACT

+905316901620; esma.aydin@bilecik.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, the statistician performing the data analysis will remain blinded to group allocation. Data will be coded, and the statistician will analyze the outcomes without knowledge of whether participants belong to the intervention or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The study sample will consist of patients undergoing preoperative hair removal in the surgical area. Participants will be randomly assigned into two groups using block randomization: standard ETM will be used in one group, and VD-ETM in the other. All procedures will be performed in the operating room under the same conditions and using the same type of clipper head. Data will be collected using a demographic form, microbial contamination measurements (CFU via petri dishes and swab samples), skin irritation assessment (visual evaluation), and a patient satisfaction questionnaire. Swab samples will be obtained before and after hair removal, environmental contamination will be measured using petri dishes, and procedure duration will be recorded. Standardization will be ensured by training all practitioner nurses. Surgical site infection will be assessed prospectively on postoperative days 7 and 30 through clinical evaluation and, if necessary, via structured telephone interviews.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)