Clipping Versus No Hair Removal and the Risk of Surgical Site Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975377
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : September 7, 2015
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation

Brief Summary:
The objective of this study is to determine whether hair clipping is non-inferior to no hair removal in preventing superficial, deep, and organ space surgical site infections (SSI) in patients undergoing various general surgical procedures, evaluated after surgery by an assessor blinded to treatment allocation. Additional goals include evaluating wound complications that arise in patients that have hair clipped and in patients that do not have hair removed and determining the impact of clipping versus no hair removal and SSI versus no SSI on length of hospital stay.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Superficial Surgical Site Infection Deep Surgical Site Infection Organ/Space Surgical Site Infection Procedure: Hair clipping Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clipping vs. No Hair Removal and the Risk of Surgical Site Infection: A Randomized, Assessor Blinded Non-inferiority Clinical Trial Among Patients Undergoing General Surgical Procedures at a Community Hospital
Study Start Date : October 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
No Intervention: No hair removal
Patients randomized to the no hair removal cohort will not undergo any preoperative hair removal.
Active Comparator: Hair clipping
Patients in the clipping cohort undergo hair removal at the surgical site. Hair removal will occur on the day of surgery immediately prior to the scheduled operation.
Procedure: Hair clipping
Patients randomized to the hair clipping cohort will be clipped using an Allegiance 4413 hair clipper. Hair removal will occur on the day of surgery by one of the preoperative nursing staff, immediately prior to the scheduled operation.

Primary Outcome Measures :
  1. To determine the proportion of patients without a surgical site infection (as defined by CDC criteria) at the postoperative assessment for patients who had hair clipped versus those with no hair removal preoperatively. [ Time Frame: 14 (+/-7) days after surgery ]

Secondary Outcome Measures :
  1. To evaluate the unanticipated need for antibiotic or surgical intervention of the wound, as well as wound cultures obtained and their results. [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Patients undergoing a general surgical procedure (inpatient or ambulatory)

Exclusion Criteria:

  • Less than 18 years of age
  • Systemic antibiotics within 1 week of surgery
  • Toe amputations
  • Ano-rectal surgery
  • Vascular surgery
  • Patients that have no need for hair to be removed for the operation
  • Inability to provide consent
  • Anticipated inability to keep 14 day follow-up appointment
  • Emergent surgical procedure
  • Patients remove their own hair prior to the operative day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975377

United States, Wisconsin
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Gundersen Lutheran Health System
Principal Investigator: Todd J. Kowalski, MD Gundersen Lutheran Health System
Principal Investigator: Shanu N. Kothari, MD Gundersen Lutheran Health System

Responsible Party: Kara Kallies, Advanced Research Associate under direction of Todd Kowalski, MD (PI), Gundersen Lutheran Medical Foundation Identifier: NCT00975377     History of Changes
Other Study ID Numbers: 2-09-05-001
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Kara Kallies, Gundersen Lutheran Medical Foundation:
hair removal
hair clipping
surgical site infection
incisional infection
wound infection

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes