NCT00975377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,678

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

September 10, 2009

Last Update Submit

September 4, 2015

Conditions

Surgical Site InfectionSuperficial Surgical Site InfectionDeep Surgical Site InfectionOrgan/Space Surgical Site Infection

Keywords

hair removalhair clippingsurgical site infectionincisional infectionwound infection

Outcome Measures

Primary Outcomes (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.

    14 (+/-7) days after surgery

Secondary Outcomes (1)

  • To evaluate the unanticipated need for antibiotic or surgical intervention of the wound, as well as wound cultures obtained and their results.

    30 days

Study Arms (2)

No hair removal

NO INTERVENTION

Patients randomized to the no hair removal cohort will not undergo any preoperative hair removal.

Hair clipping

ACTIVE COMPARATOR

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

Interventions

Hair clippingPROCEDURE

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.

Hair clipping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (3)

  • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

    PMID: 10196487BACKGROUND

  • Tanner J, Woodings D, Moncaster K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004122. doi: 10.1002/14651858.CD004122.pub3.

    PMID: 16856029BACKGROUND

  • Kowalski TJ, Kothari SN, Mathiason MA, Borgert AJ. Impact of Hair Removal on Surgical Site Infection Rates: A Prospective Randomized Noninferiority Trial. J Am Coll Surg. 2016 Nov;223(5):704-711. doi: 10.1016/j.jamcollsurg.2016.03.032.

    PMID: 27687471DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Todd J. Kowalski, MD

    Gundersen Lutheran Health System

    PRINCIPAL INVESTIGATOR

  • Shanu N. Kothari, MD

    Gundersen Lutheran Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Research Associate under direction of Todd Kowalski, MD (PI)

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(1)