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The Effect of Hair Removal on Intraoperative Contamination

NCT04256928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-10

No results posted yet for this study

Summary

A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.

The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.

200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled.

During surgery, four microbiological samples will be taken from each participant.

The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples.

If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.

Conditions

  • Intraoperative Complications

Interventions

PROCEDURE

Preoperative electrical clipping

Body hair in the operative field will be clipped with an electrical clipper by hospital personnel during preparation to planned surgery.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

Principal Investigators

  • Ditte Harder, Student · Herlev og Gentofte Hospital, Ortopædkirurgisk Afdeling T

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2020-06-30
Completion
2020-07-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256928 on ClinicalTrials.gov