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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT00975377
First received: September 10, 2009
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Surgical Site Infection
Superficial Surgical Site Infection
Deep Surgical Site Infection
Organ/Space Surgical Site Infection
 Procedure: Hair clipping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Gundersen Lutheran Medical Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975377

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

Publications:

Responsible Party: Kara Kallies, Advanced Research Associate under direction of Todd Kowalski, MD (PI), Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT00975377     History of Changes
Other Study ID Numbers: 2-09-05-001
Study First Received: September 10, 2009
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013