Original Research
ajog.org
GYNECOLOGY
Chlorhexidine gluconate vs povidone-iodine vaginal
antisepsis for urogynecologic surgery: a randomized
controlled noninferiority trial
Nicholas F. Rockefeller, MD; Timothy R. Petersen, PhD; Yuko M. Komesu, MD; Kate Meriwether, MD; Gena Dunivan, MD;
Cara Ninivaggio, MD; Peter C. Jeppson, MD
BACKGROUND: Although povidone-iodine (iodine) is the only Food
and Drug Administrationeapproved vaginal antiseptic solution, there is a
lack of comparative data evaluating alternatives. Chlorhexidine gluconate
is readily accessible, recommended by multiple societies as an alternative
for patients with iodine allergy, and preliminary data indicate that it may
provide superior antisepsis.
OBJECTIVE: This study aimed to compare the effectiveness of chlorhexidine and iodine as presurgical vaginal antiseptic solutions in preventing the most common surgery-associated infection after gynecologic
surgery, urinary tract infections.
STUDY DESIGN: We conducted a randomized controlled noninferiority
trial among women undergoing urogynecologic surgery. The primary
outcome measure was symptomatic urinary tract infection within 2 weeks
after surgery. The secondary outcomes included culture-proven urinary
tract infection at 2 and 6 weeks after surgery, symptomatic urinary tract
infections at 6 weeks after surgery, any surgical site infection at 2 weeks
after surgery, and patient-reported vaginal irritation after surgery. We
required 58 participants per arm to demonstrate noninferiority of chlorhexidine vs iodine (margin of relative risk of <1.5 for the upper limit of
95% confidence interval) between groups for the primary outcome.
RESULTS: A total of 119 participants (61 in the chlorhexidine
group and 58 in the iodine group) completed the primary outcome
Introduction
Urinary tract infections (UTIs) and
surgical site infections (SSIs) are common concerns for postoperative
morbidity after urogynecologic surgery.
Of note, 7% to 33% of women will
report a postoperative UTI,1,2 and 0.6%
to 1.3% of women will experience an SSI
after urogynecologic surgery.3,4 These
postoperative infections are associated
with increased healthcare costs, antibiotic resistance, and morbidity and
mortality for patients. A recent study
Cite this article as: Rockefeller NF, Petersen TR, Komesu
YM, et al. Chlorhexidine gluconate vs povidone-iodine
vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet
Gynecol 2022;227:66.e1-9.
0002-9378/$36.00
ª 2021 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.ajog.2021.12.260
and were included in the analyses. There was no difference in the
groups’ demographic characteristics, medical history, operations
performed, or perioperative factors. Chlorhexidine was not inferior to
iodine concerning the primary outcome, symptomatic urinary tract
infection at 2 weeks after surgery (10% vs 17%; relative risk, 0.6;
95% confidence interval [-N, 1.3]). Furthermore, chlorhexidine was
not inferior to iodine for the secondary urinary tract infection outcomes (culture-proven urinary tract infection at 2 and 6 weeks after
surgery and symptomatic urinary tract infection at 6 weeks after
surgery). Groups were similar in terms of surgical site infection
(overall 3/119 [2.5%]) and presence of any vaginal irritation (4/54
[7.4%], for both groups).
CONCLUSION: Chlorhexidine was not inferior to iodine for vaginal
antisepsis before urogynecologic surgery concerning urinary tract infection. Given the similar postoperative urinary tract infection rates demonstrated in this study and the lack of difference in vaginal irritation,
chlorhexidine seemed to be a safe and reasonable option for vaginal
antisepsis before surgical procedures. Additional studies are needed to
further examine surgical site infection.
Key words: randomized controlled trial, surgical antiseptic, surgical site
injection, urinary tract infection, urogynecologic surgery
found that SSIs account for 31% of all
healthcare-associated infections among
hospitalized patients.5 Postoperative infections are used as a quality metric and
tracked by regulatory bodies, such as The
Joint Commission, the Centers for
Medicare and Medicaid Services, and the
National Surgical Quality Improvement
Program.
Surgical operations are categorized on
the basis of inherent infection risks:
clean, clean-contaminated, contaminated, and dirty or infected.6 Any surgery that passes through or into the
vagina is classified as a cleancontaminated surgery as the inherent
vaginal microbiota are known to increase the risk of postoperative infections.6 To decrease the risk of
infections after surgery, best practices
recommend preoperative antiseptic
cleaning of the vaginal surgical field.7,8
66.e1 American Journal of Obstetrics & Gynecology JULY 2022
For abdominal surgery, several studies
have demonstrated that that chlorhexidine gluconate (CHG) antisepsis results
in fewer postoperative infections than
povidone-iodine (iodine) for abdominal
hysterectomies and cesarean deliveries,
with 44% and 22% lower odds for those
surgical procedures, respectively.9,10 The
prolonged antiseptic effect of CHG is
theorized to contribute to decreased
infection rates. Iodine has been reported
to be effective for 2 hours, whereas
CHG’s duration of action has been reported to last for 6 to 48 hours,
depending on the alcohol concentration
used.11 Therefore, CHG is the preferred
antiseptic of choice before abdominal
surgical procedures.8,12
For vaginal surgery, iodine is
currently the only Food and Drug
Administrationeapproved antiseptic
agent. Because of this, some
ajog.org
GYNECOLOGY
AJOG at a Glance
Why was this study conducted?
Urinary tract infection (UTI) is a common cause of postoperative morbidity in
urogynecologic surgery, and there are few options for preoperative antisepsis.
This study aimed to compare the risk of UTI postoperatively after urogynecologic
surgery.
Key findings
This randomized controlled trial compared vaginal chlorhexidine with iodine,
examining the risk of postoperative infection. Chlorhexidine was not inferior to
iodine for prophylaxis of UTI at 2 weeks before surgery. The groups had similar
rates of surgical site infection and vaginal irritation.
What does this add to what is known?
Study findings have offered clinical information regarding an alternative to iodine
for vaginal antisepsis. This can inform hospital antiseptic policies.
institutions limit or restrict the use of
CHG in the vagina. However, some
have found CHG to be a safe and
effective vaginal antiseptic,13 and the
American College of Obstetricians and
Gynecologists lists either CHG or
iodine as an acceptable preoperative
vaginal antiseptic agent.12
This study aimed to evaluate the
comparative effectiveness of 2 preoperative vaginal antiseptic solutions (CHG
and povidone-iodine) before urogynecologic surgery. As UTI is the most
common infection after urogynecologic
surgery, our primary objective was to
compare the rates of symptomatic UTI
between the 2 antiseptic agents within
the first 2 weeks after surgery. We hypothesized that CHG would be noninferior to iodine concerning the
prevalence of UTI within the first weeks
after surgery.
Materials and Methods
We obtained institutional review board
approval (Human Research Review
Committee #19-039) to perform a
single-masked, noninferiority, randomized controlled trial (RCT) to compare
the effectiveness of CHG vs iodine for
presurgical vaginal antiseptic cleaning
before any urogynecologic surgery
involving vaginal preparation, and we
registered the trial on ClinicalTrials.gov
(NCT04048356). We recruited participants scheduled for urogynecologic
surgery in the University of New Mexico
Health System between August 2019 and
January 2021.
The inclusion criteria included English- or Spanish-speaking female participants aged 18 years undergoing
urogynecologic surgical procedures who
could provide informed consent. We
excluded women that were pregnant or
incarcerated and those without telephone access, those unable to return for
follow-up, those having surgical procedures without the concurrent need for
vaginal antisepsis (such as cases of sacral
neuromodulation), or those with a
known allergy to either chlorhexidine or
iodine.
Patients received perioperative care
that included a physical examination and
any necessary diagnostic studies needed
for their preoperative workup. Informed
consent was obtained before enrollment.
All patients received standard perioperative antibiotic prophylaxis, including
intravenous antibiotics within 30 minutes of the surgical start time if indicated for the procedure.12
Participants were randomly assigned
to receive a standardized aqueous preoperative scrub with either 10% iodine
or 2% CHG, which was conducted in a
standardized fashion as described by AlNiaimi et al.13 Randomization was performed after enrollment but before surgery. A blocked randomization schema
was used to determine the allocation,
and randomization was performed by
research staff not in the operating room
Original Research
and communicated to surgical staff
through secure digital software.
Participants were masked as they were
not informed regarding which intervention they received while being anesthetized before their procedure. It was
not feasible to mask the surgeon, as the 2
antiseptic preparations look distinctly
different after application. Outcomes
assessors were masked to the allocation
as the allocation was not included in the
medical record.
The primary outcome was the rate of
symptomatic UTIs within 2 weeks after
surgery. The secondary outcomes
included vaginal irritation based on a 5point Likert scale on postoperative day 1;
symptomatic, culture-proven UTI
within 2 weeks after surgery (defined as
10,000 colony-forming units); SSIs
within 2 weeks after surgery; and any
symptomatic UTI up to 6 weeks after
surgery.
We conducted a sample size calculation based on a noninferiority study
design and a between-group difference
of 10% (or 50% overall UTI rate
relative difference) using a baseline
postoperative UTI estimate of 20%
based on the range found in the urogynecologic literature.1,2 This demonstrated that we would need 58
participants per group (CHG vs iodine)
to detect noninferiority for our primary
outcome with an alpha of 0.05 and with
80% power. Assuming a dropout rate of
20%, we anticipated enrolling at least
146 participants but planned to
continue to recruit participants until we
reached our primary endpoint of 2 week
follow-up for 116 participants or 58
participants in each group. We later
increased the anticipated enrollment
numbers to allow up to 200 participants
because of COVID-19 surgical rescheduling and cancellations to reach power
for our primary outcome.
We evaluated between- and withingroup differences using the Fisher exact
test for categorical variables and t tests
for continuous variables. Intention-totreat analyses were performed for primary and secondary outcomes. Next, we
performed per-protocol analyses to
determine if treatment received significantly altered the results. An inferiority
JULY 2022 American Journal of Obstetrics & Gynecology
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GYNECOLOGY
FIGURE 1
Flow diagram of the study participants
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
margin of relative risk (RR) of 1.50 was
selected. Our null hypothesis was that
CHG was not noninferior to iodine; in
this case, the upper limit of the 95%
confidence interval (CI) would exceed
1.50. As the test was single sided, our
expected 95% CI would be single
bounded, with the lower limit extending
to negative infinity. The reason for this
selection was to amplify our examination
of the upper limit of the 95% CI. For
other analyses, a threshold of P<.05 was
selected to denote statistical significance.
Statistical analyses were conducted using
the JMP software (version 9.0.0; SAS
Institute Inc, Cary, NC). The study followed the Consolidated Standards of
Reporting Trials (CONSORT) guidelines
for reporting randomized trials.
Results
A total of 158 participants met the
eligibility criteria and were subsequently
enrolled in the study from August 2019
to January 2021. Figure 1 reports the
disposition of participants according to
the CONSORT guidelines.14 Of note, 3
participants were initially offered
participation; however, on review, the
participants were noted to have an allergy to one of the antiseptic agents and
therefore were excluded from the study
before enrollment. Moreover, 2 participants had surgical delays because of
medical issues, and an additional 19
participants were enrolled but never had
surgery because of operating room
closure
during
the
COVID-19
pandemic; these 21 participants were
removed from the study before
randomization. The remaining 137 participants were randomized; 65 and 72
participants were allocated to iodine and
CHG, respectively. In addition, 119
participants completed the primary
outcome at 2 weeks follow-up for
symptomatic UTI, and 18 participants
were lost to follow-up. However, 1
66.e3 American Journal of Obstetrics & Gynecology JULY 2022
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protocol deviation occurred, and the
participant received iodine instead of
CHG and was analyzed on the basis of
intention to treat.
Baseline demographic characteristics
and pertinent medical and surgical histories of the study participants are
shown in Table 1. There was no statistically significant difference between the
groups in any baseline characteristics.
Surgical details are described in the
Appendix; there was no statistically significant difference between the iodine
and CHG groups in surgery type (hysterectomy, P¼.88; apical suspension,
P¼.99; midurethral sling, P¼.28), perioperative antibiotics (P¼.99), operative
time (123105 vs 120115 minutes;
P¼0.49), or Foley catheter use intraoperatively (93% vs 93%; P>.99) or at
discharge (23% vs 17%; P¼.35). Additional surgical classifications can be
found in the Appendix.
The primary outcome is presented in
Table 2 and reported as RR with 95% CI.
The risk of symptomatic UTI at 2 weeks
after surgery was lower in the CHG
group (10% vs 17%; RR, 0.57; 95% CI
[-N, 1.26]), and the upper limit of the
95% CI did not exceed our predetermined inferiority margin of RR of
1.50, demonstrating that CHG is noninferior to iodine. Again, as our test was
1-sided, the lower limit of the 95% CI
extended to negative infinity. The noninferiority limit is illustrated in Figure 2.
Of note, the data presented here were for
the intention-to-treat analysis. Perprotocol analysis did not change the
noninferiority result of the primary
outcome. Furthermore, the secondary
outcome of culture-proven UTI at 2
weeks after surgery demonstrated noninferiority (Table 2). Because of the loss
of participants to follow-up, the secondary outcomes of symptomatic UTI
and culture-proven UTI at 6 weeks after
surgery were underpowered to demonstrate noninferiority, although the 95%
CI did not exceed predetermined noninferiority margins (Table 2). There was
no statistical difference between groups
concerning SSI at 2 weeks after surgery
between iodine and CHG groups (3.4%
vs 1.6%; P¼.48) (Table 3). The prevalence of patient-reported vaginal
ajog.org
GYNECOLOGY
urethral injury at the time of aborted
midurethral sling placement.
TABLE 1
Demographic characteristics
Characteristic
Povidoneiodine
Chlorhexidine
gluconate
P value
Patients, n
58
61
—
Age (y), meanSD
5712
5813
Ethnicity
African American
0 (0)
20 (34)
30 (49)
Latino or Hispanic
25 (43)
26 (42)
American Indian
12 (21)
5 (8)
4 (7)
2 (3)
0 (0)
1 (2)
Private
24 (41)
30 (49)
Medicaid of Medicare
26 (45)
32 (52)
4 (7)
5 (8)
Other
Assisted living or nursing facility
Health insurance
VA Healthcare
.54
.10
2 (3)
White
.51
.98
Self-pay
0 (0)
1 (2)
Other or unknown
9 (16)
9 (15)
39 (67)
42 (69)
.99
Menopausal
Hormone replacement
Vaginal estrogen
11 (19)
17 (28)
.35
Hormonal birth control pills
4 (7)
2 (3)
.63
Overactive bladder medications
4 (7)
6 (10)
.80
Overactive bladder procedures
5 (7)
7 (11)
.83
Recurrent UTI
9 (16)
17 (28)
.15
Current prophylactic antibiotics
for recurrent UTI
2 (3)
4 (7)
.63
Diabetes mellitus
7 (13)
9 (15)
.87
Tobacco smoking
4 (7)
8 (13)
.41
24 (41)
19 (31)
.33
6 (10)
8 (13)
.85
Previous hysterectomy
Previous prolapse surgery
Original Research
Data are presented as number (percentage), unless otherwise indicated. The Fisher exact test was used for categorical variables, and the t test was used for continuous variables.
SD, standard deviation; UTI, urinary tract infection; VA, Veterans Administration.
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
irritation was not significantly different
between groups on postoperative day 1
(P¼.51) (Table 3). Per protocol analysis
did not affect the noninferiority of the
CHG to iodine concerning the primary
outcome.
Of note, 8 participants reported
adverse events (AE), 4 in the iodine
group and 4 in the CHG group. In the
iodine group, 2 participants reported SSI
(1 superficial perineal infection and 1
superficial retropubic sling trocar exit
site infection), 1 non-SSI stitch abscess, 1
participant reported postoperative
bronchitis. In the CHG group, 1 participant developed vaginal cuff cellulitis, 1
participant reported bacterial vaginosis,
1 participant reported self-limited
delayed vulvar skin irritation 72 hours
after surgery, and 1 participant had a
Discussion
Principal findings
We found that, for the prevention of
postoperative UTI up to 2 weeks after
surgery, CHG was not inferior to iodine
for women undergoing urogynecologic
surgery. In addition, there was no identified difference in SSI, vaginal irritation,
AE, or UTI at 6 weeks after surgery.
Based on this information, it would seem
that either CHG or iodine would be an
appropriate perioperative antiseptic
agent.
Results in the context of what is
known
We selected UTI prevalence at 2 weeks
after surgery as our primary outcome
because UTIs are a large contributor to
healthcare costs and patient morbidity
and are relatively common after urogynecologic surgery. This study was an
RCT that compared CHG and iodine for
vaginal antiseptic for urogynecologic
surgical procedures with the primary
outcome of postoperative UTI.
Although our study was not powered to
examine SSI, their occurrence did not
seem to differ between groups. In addition, we were not powered to detect a
definitive difference in vaginal irritation
between the cohorts, but the prevalence
of reported irritation did not differ between groups. The overall irritation level
was low, occurring in approximately 7%
of women in each group. There was no
event involving severe vaginal irritation
requiring inpatient treatment, a side effect that was reported after vaginal antisepsis in a 2004 case report.15 There are
anecdotal reports of hospital systems or
locations in which CHG is not used as a
matter of policy secondary to the risk of
epithelial desquamation. Our findings
did not seem to support these policies,
given that we rigorously surveyed participants for such AEs and did not detect
any instances of this. CHG seemed to be
a safe, reasonable option for vaginal antisepsis and should certainly be an
acceptable option for women with an
iodine allergy. The significance of our
findings relates to increasing the number
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GYNECOLOGY
TABLE 2
Urinary tract infection outcome measures
Outcome
Iodine
Chlorhexidine Gluconate
Relative risk (95% CI)a
2-wk symptomatic UTI
10/58 (17)
6/61 (10)
0.57 (-N, 1.26)a
2-wk culture proven UTI
7/58 (12)
4/61 (7)
0.54 (-N, 1.46)a
6-wk symptomatic UTI
15/51 (29)
11/55 (20)
0.68 (-N, 1.20)a
6-wk culture proven UTI
10/51 (20)
7/55 (13)
0.65 (-N, 1.36)a
Data are presented as number/total number (percentage), unless otherwise indicated. The Fisher exact test was used for categorical variables.
a
Denotes statistical significance.
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
of safe, acceptable options available to
surgeons at the time of vaginal urogynecologic surgery for the prevention of
postoperative infections. Apart from
iodine and CHG, few data are available
regarding aseptic techniques for the
prevention of infections after gynecologic surgery. Before the use of chlorhexidine, some older literature even
recommends the use of a saline wash to
reduce vaginal flora in the case of an
iodine allergy.16 Confirmation of the
safety and efficacy of existing antiseptic
agents is of particular importance given
the difficulty in navigating real or
spurious patient iodine allergies, which
range from 2% to 17% of the
population.17
Clinical implications
Postoperative infections are problematic
complications that are costly for quality
of recovery, quality of life, health system
finance. We chose UTI prevalence in the
short term (2 weeks) as our primary
outcome because urogynecologic surgery is a known risk of UTI despite the
use of preoperative antibiotics and antiseptic preparations. UTIs are one of the
most common complications of these
urogynecologic surgical procedures with
rates ranging from 7% to 33%.1,4 SSIs,
FIGURE 2
Noninferiority margin: symptomatic UTI at 2 weeks after surgery
Chlorhexidine Worse
Chlorhexidine Not Worse
Non-inferior
Inferior
Relative Risk (95% Confidence Interval)
RR 0.6 ([-∞]-1.3)
Non-inferiority Margin
RR 1.5
0
0.5
1
1.5
2.0
3.0
Relative Risk
RR with 95% confidence interval of UTI is illustrated, with the noninferiority margin superimposed as
the dotted line.
RR, relative risk; UTI, urinary tract infection.
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
66.e5 American Journal of Obstetrics & Gynecology JULY 2022
which are less common but typically
more serious, are an additional source of
morbidity, mortality, and healthcare
costs.4 Of note, 1 posited source of
infection in vaginal surgery is the spread
of vaginal bacteria to surgical incisions
or underlying structures at the time of
surgery.18 It stands to reason that
decreasing total vaginal bacterial counts
just before surgery would decrease the
risk of infection. As SSIs are less common than UTIs, studies examining SSIs
as a primary outcome would require a
prohibitively large sample size. Interestingly, 1 study used intraoperative vaginal
swabs to obtain bacterial colonies as a
surrogate of SSI; this study showed fewer
bacteria sampled serially during a vaginal
hysterectomy with CHG vs iodine.18
This corroborated the notion that CHG
has a longer residual effect at the site of
application vs iodine. In studies examining the prevention of postoperative
endometritis at the time of cesarean delivery, vaginal iodine and CHG have
been compared with mixed results,19,20
and a large systematic review did not
identify the benefit of 1 preparation vs
the other for cesarean delivery.21 Given
these studies that do not show a clear
superiority of 1 preparation vs another, a
noninferiority design was selected to
determine if CHG would serve as a safe
and effective option for urogynecologic
surgery.
Research implications
Future studies could evaluate the equivalence or superiority of 1 agent vs
another or evaluate the differences in SSI
rather than UTI. In particular, equivalence could be a useful finding in any
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GYNECOLOGY
Original Research
TABLE 3
Secondary outcome measures
Outcome
Iodine
Chlorhexidine gluconate
Relative risk (95% CI)
P value
Surgical site infection at 2 wk
2/58 (3.4)
1/61 (1.6)
0.47 (0.04e5.10)
.48
Vaginal irritation
.51
0
50/54 (92)
50/54 (92)
—
—
1
0/54 (0)
1/54 (2)
—
—
2
0/54 (0)
1/54 (2)
—
—
3
2/54 (4)
0/54 (0)
—
—
4 or 5
2/54 (4)
2/54 (4)
—
—
Data are presented as number/total number (percentage), unless otherwise indicated. The Fisher exact test was used for categorical variables.
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
eventual cost analysis study examining
the differing financial burdens to
healthcare systems between preoperative
antiseptics. Furthermore, this study
design could be applied to other surgical
subspecialties, including urology, general gynecology, or colorectal surgery, all
of which perform surgical procedures
that involve the potential risk of postoperative UTI and include vaginal antiseptic use. Moreover, other antiseptic
agents could be examined to broaden the
arsenal of aseptic preparations.
Strengths and limitations
Our study has several strengths, the first
of which is the study design. This was a
prospective RCT that minimized many
forms of bias. Second, the primary and
secondary outcomes were patient reported and clinically meaningful, and
the reporting bias in these outcomes was
reduced by the single-masked nature of
this study. Third, this study included a
racially and ethnically diverse group,
including a substantial representation of
Hispanic and Native American participants. Finally, the inclusion of multiple
types of urogynecologic operations
requiring vaginal antiseptic preparation
broadened the scope of applicability to
many common procedures performed in
urogynecologic practice.
Furthermore, there were limitations
to our study; despite the trial’s singlemasked design, surgeons could not be
masked to the antiseptic agent secondary
to the colors of the commercially available solutions. This could lead to some
bias by the treating surgeon concerning
the diagnosis and treatment of UTI. This
risk was mitigated by lack of identification of antiseptic used in the patient
medical record and by systematic triage
of postoperative patient concerns by
someone other than the investigators. In
addition, this study was conducted at a
tertiary care center, which may decrease
the generalizability to less specialized
centers. Although our participant population was diverse, African American
and Asian participants were not well
represented in our sample. Finally, we
were underpowered for secondary outcomes, such as SSI and vaginal irritation.
Conclusions
Among women who had urogynecologic
surgery, CHG seemed to be a safe and
reasonable option for vaginal antisepsis
concerning UTI risk. Vaginal irritation
and SSI rates were similar to previously
published studies, and the risk between
groups was similar.
n
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Author and article information
From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health
Science Center, Albuquerque, NM (Drs Rockefeller,
Komesu, Meriwether, Dunivan, Ninivaggio, and Jeppson);
and Department of Anesthesia and Critical Care Medicine, University of New Mexico Health Sciences Center,
66.e7 American Journal of Obstetrics & Gynecology JULY 2022
ajog.org
University of New Mexico, Albuquerque, NM (Dr
Petersen).
Received Aug. 24, 2021; revised Nov. 29, 2021;
accepted Dec. 24, 2021.
G.D. reports receiving research support from Pelvalon and Viveve. K.M. reports receiving book royalties
from Elsevier Publishing, travel stipend for position as
research chair of the Society of Gynecologic Surgeons
(voting board position), and consultant fees for RBI
Medical. C.N. reports receiving research support from
Cook MyoSite. P.C.J. reports receiving consultant fees
for Ethicon. The remaining authors report no conflict of
interest.
This study received no extramural funding.
This study has been registered on ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/show/NCT04048356;
ClinicalTrials.gov Identifier: NCT04048356) on August 7,
2019. Enrollment of participants was on August 7, 2019.
The data, study protocol, and statistical analysis plan are
available for sharing if required. Data will be available
indefinitely pending future research database availability.
Data will be shared for use of meta-analysis or data
pooling.
Corresponding author: Nicholas F. Rockefeller, MD.
nrockefeller1187@gmail.com
ajog.org
GYNECOLOGY
Original Research
Appendix
SUPPLEMENTAL TABLE
Surgical operations and perioperative data
Surgical operation
Povidone-iodine
Chlorhexidine gluconate
Hysterectomy
13
14
P value
.88
Vaginal
6
8
.65
Laparoscopic
4
4
.99
Laparoscopically- assisted vaginal
1
0
.97
Abdominal
0
0
—
Robotic
2
2
.99
Suspension
19
20
.99
Vaginal uterosacral
4
7
.47
Laparoscopic uterosacral
1
1
.99
Sacrospinous ligament fixation
6
2
.24
Laparoscopic sacrocolpopexy
3
7
.66
Robotic sacrocolpopexy
5
3
.66
Abdominal sacrocolpopexy
0
0
—
Vaginal mesh suspension
0
0
—
Colporrhaphy
10
6
.36
Anterior
6
5
.92
Posterior
5
1
.18
Perineorrhaphy
16
16
.99
Colpocleisis
11
6
.24
Midurethral sling
37
32
.28
Retropubic
20
20
.99
Transobturator
17
11
.21
Mesh excision
1
1
.99
Urethropexy
0
0
Pubovaginal sling
2
0
.47
51
53
.31
Cystoscopy
—
Hydrodistension
0
3
.26
Intradetrusor Botox
3
2
.95
Hunner ulcer injection
0
0
—
Hunner ulcer fulguration
0
0
—
Levator Botox injection
3
5
Pudendal nerve block
2
2
Periurethral bulking
0
0
—
Urethral diverticulum repair
0
0
—
Fistula repair
0
1
.99
Intraoperative bladder catheterization
54
57
.99
Catheter at discharge
11
9
.35
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
.77
.99
(continued)
JULY 2022 American Journal of Obstetrics & Gynecology
66.e8
Original Research
ajog.org
GYNECOLOGY
SUPPLEMENTAL TABLE
Surgical operations and perioperative data (continued)
P value
Surgical operation
Povidone-iodine
Chlorhexidine gluconate
Preoperative antibiotics
56
59
.99
Cefazolin
51
51
.68
Ciprofloxacin
1
2
.99
Clindamycin
1
6
.13
Gentamicin
1
6
.13
Metronidazole
1
1
.99
Cefoxitin
0
0
—
Aztreonam
0
0
—
123105
120115
Operative time (min)
Rockefeller et al. Vaginal chlorhexidine and iodine in urogynecologic surgery. Am J Obstet Gynecol 2022.
66.e9 American Journal of Obstetrics & Gynecology JULY 2022