Clipping Versus No Hair Removal and the Risk of Surgical Site Infections
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.
Surgical Site Infection
Superficial Surgical Site Infection
Deep Surgical Site Infection
Organ/Space Surgical Site Infection
Procedure: Hair clipping
|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|
- 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 ]
- 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 ]
|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)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00975377
|United States, Wisconsin|
|Gundersen Lutheran Health System|
|La Crosse, Wisconsin, United States, 54601|
|Principal Investigator:||Todd J. Kowalski, MD||Gundersen Lutheran Health System|
|Principal Investigator:||Shanu N. Kothari, MD||Gundersen Lutheran Health System|