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

Public health organizations, third party payers, consumer watchdog groups, health care
quality organizations, and patients are increasingly scrutinizing patient safety in
hospitals. Surgical site infection (SSI) rates are one of the key quality measures by which
hospitals are evaluated. Centers for Disease Control (CDC) guidelines provide specific
recommendations, weighted by evidence, to prevent SSI. These include the following category
1A recommendations (Strongly recommended for implementation and supported by well-designed
experimental, clinical, or epidemiological studies).

- Do not remove hair preoperatively unless the hair at or around the incision site will
interfere with the operation

- If hair is removed, remove immediately before the operation, preferably with electric
clippers.

However, a recent systematic review of randomized clinical trials concluded there was no
difference in SSI among patients that had hair removed prior to surgery and those that did
not. Furthermore, trials involving hair removal were largely underpowered and of marginal
quality. If hair is going to be removed, previous studies have shown hair removal with
clippers or depilatory creams to result in fewer SSI than shaving with a razor. However, the
need for trials comparing SSI rates with and without hair removal was stressed in the recent
systematic review. No prospective, randomized clinical trial evaluating no hair removal vs.
hair removal by clipping, the two hair removing modalities preferred by CDC SSI prevention
guidelines, has ever been reported. This study aims to assess whether hair removal via
clipping is non-inferior to no hair removal in a cohort of patients undergoing general
surgical procedures at a community hospital.

A non-inferiority study design will be used based upon the following rationale. CDC
guidelines recommend not removing hair preoperatively unless the hair will interfere with
the operation. However, there is no published evidence that clipping hair results in more
SSI than no hair removal. Clipping hair is often preferred from a surgical perspective. This
may be because of historical practice patterns, personal comfort level, and the either real
or perceived interference of unremoved hair with performing the operation. Therefore,
assessing whether clipping is non-inferior to no hair removal will provide helpful
information regarding the appropriateness of the current CDC recommendation to not remove
hair preoperatively unless the hair will interfere with the operation.

Patients will be assessed for enrollment after a decision has been made for elective
(non-emergent) operative intervention. Patients will undergo our institution's current
preoperative procedural standard of care. Patients will be specifically instructed to not
shave themselves prior to the procedure. The day of the procedure patients will undergo our
institution's standard preoperative skin preparation, which currently includes povidone
based skin antiseptic. Preoperative antibiotics will be administered according to our
institutional standards of care for their particular operation.

Randomization will be assigned the day of surgery in the preoperative area. Patients will be
randomized 1:1 to either undergo clipping or no hair removal. Enrolled patients will then
undergo the type of hair removal appropriate for their study arm. Clipping patients will
undergo hair removal on the day of surgery by a member of the preoperative nursing staff,
immediately prior to the scheduled operation. Any patient that undergoes unanticipated hair
removal, (either additional hair removal in patients that were clipped or any hair removal
in patients that were not clipped) will be noted as a protocol deviation and the event
recorded. Patients will undergo their surgical procedure according to standard surgical
care.

Patients will be scheduled for a follow-up wound assessment with a trained study nurse. This
assessment will take place by an independent assessor whom is blinded (as best able given
study interventions) to the study group the patient was in.

Additionally, if patients are seen for wound problems by their surgeon, primary physicians,
or other physicians we will attempt to have them evaluated by one of the trained nurses at
that visit as well. If patients do not keep their follow-up appointment, they will be called
and asked a standardized set of questions related to the wound. Finally, in the event
patients are seen for wound problems at other facilities, or in other departments (i.e.
urgent care, emergency room, etc), they will be encouraged to make a follow-up appointment
within a few days to be reassessed, at which time the study nurse can assess their status as
well. The patients' electronic medical records will be updated to reflect their study
involvement, and to alert providers to contact the study coordinator with wound related
questions if seen in another department.

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