Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Kristina A. Wihbey, MD, Ellen M. Joyce, MD, Zachary T. Spalding, MD, Hayley J. Jones, MD,
Todd A. MacKenzie, PhD, Rebecca H. Evans, MD, June L. Fung, PhD, Marlene B. Goldman, MS, ScD,
and Elisabeth Erekson, MD, MPH
OBJECTIVE: To compare the occurrence of superficial months, an interim analysis for futility was conducted
surgical site infections in obese women using prophy- and the decision was made to halt the study.
lactic negative pressure therapy with standard dressings RESULTS: Women were recruited between January 5,
after cesarean delivery. 2015, and January 7, 2017, from two sites. The mean BMI
Methods: We conducted a randomized controlled, non- on admission was 44.9 (68) for the prophylactic negative
blinded, two-center study of prophylactic negative pres- wound therapy group and 43.4 (67) for the standard dress-
sure therapy compared with standard surgical dressings ing group. There were no differences in the occurrence of
placed at the time of primary closure at cesarean delivery observed superficial surgical site infections between
in obese women with body mass indexes (BMI) of 35 or women using prophylactic negative pressure wound ther-
higher (ie, class II and III obesity). Our primary outcome apy (12/80 [15%]) compared with women who received the
was occurrence of a superficial surgical site infection. We standard dressing (8/81 [10%], P5.35, relative risk 1.52, 95%
assumed a superficial surgical site infection occurrence CI 0.66–3.52). There were no differences in the occurrence
rate of 20% and intended to recruit 400 women. of composite wound complications between women using
However, after low enrollment of 166 women over 24 prophylactic negative pressure wound therapy (25/80
[31%]) compared with women who received the standard
From the Departments of Obstetrics and Gynecology and Biomedical Data dressing (24/81 [30%], P5.87).
Science and the Dartmouth Institute for Health Policy and Clinical Practice, the
Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.
CONCLUSION: In this randomized controlled trial that
did not achieve full anticipated enrollment, we did not
The devices used in this study were provided by an unrestricted research grant
from KCI Medical (San Antonio, Texas). KCI Medical had no role in the study observe a decrease in superficial surgical site infections
design, data collection, or data analysis. Final results of the study were shared after cesarean delivery in obese women with the use of
with the company before manuscript submission; however, the investigators were prophylactic negative pressure wound therapy.
not bound to incorporate KCI’s comments. The authors’ decision as to what the
manuscript contained was final. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
Each author has indicated that he or she has met the journal’s requirements for NCT02390401.
authorship. (Obstet Gynecol 2018;132:377–84)
Received February 6, 2018. Received in revised form May 4, 2018. Accepted May DOI: 10.1097/AOG.0000000000002744
15, 2018.
Corresponding author: Kristina A. Wihbey, MD, Department of Obstetrics and
Gynecology, The Geisel School of Medicine at Dartmouth, 189 N Main Street,
Concord, NH 03301; email: kwihbey@crhc.org.
T he prevalence of obesity (defined as body mass
index [BMI, calculated as weight (kg)/[height
(m)]2] 30 or higher) continues to increase, affecting
Financial Disclosure
The authors did not report any potential conflicts of interest. approximately 40% of adult females in the United
© 2018 by the American College of Obstetricians and Gynecologists. Published
States according to Centers for Disease Control and
by Wolters Kluwer Health, Inc. All rights reserved. Prevention 2013–2014 statistics.1 Obesity has a signif-
ISSN: 0029-7844/18 icant effect on many aspects of pregnancy, including
378 Wihbey et al Prophylactic Negative Pressure Wound Therapy OBSTETRICS & GYNECOLOGY
VOL. 132, NO. 2, AUGUST 2018 Wihbey et al Prophylactic Negative Pressure Wound Therapy 379
one of the following: 1) purulent drainage from the distributions were used as appropriate. We first com-
wound or 2) organism identified by culture or wound pleted an observed outcome analysis based on
deliberately opened by the surgeon. Patients also observed outcomes for the women who completed
needed to have at least one of the following symp- their 1-week postoperative incision check. We then
toms: pain, swelling, or erythema. Our secondary calculated an unadjusted relative risk and 95% CI for
outcome was a composite wound complication, the primary outcome. We then completed a second
including superficial, deep, or organ-space surgical outcome analysis for all women who were random-
site infection; wound dehiscence; seroma; or hema- ized and received their intended treatment despite
toma that occurred within 30 days of surgery. Other lack of follow-up at the 5- to 7- day incision check
secondary outcomes included 30-day readmission, by imputing missing data. We assumed that all
30-day reoperation, and need for antibiotic treatment women who were lost to follow-up had developed
for any reason (eg, mastitis, urinary tract infection, superficial surgical site infections. For the secondary
pyelonephritis). We also examined length of stay outcome of composite wound complication, we
after cesarean delivery and rates of breastfeeding at assumed that complications that would not require
discharge this seems to have been erroneously dupli- readmission happened (eg, seroma, hematoma, or
cated. We had already stated this earlier in the text. wound dehiscence) and we assumed that complica-
Additional outcomes were determined by chart tions that would generally require inpatient readmis-
review. sion did not happen (eg, deep surgical site infections
Standard statistical methods such as frequency or organ-space surgical site infections). Finally, we
distributions and measures of central tendency were conducted two subgroup analyses of women with
used to evaluate the demographic and clinical BMIs of 40 to 50 and BMIs of 50 or higher to see
characteristics of the participants. Pearson x2, Fisher whether these groups had differences in superficial
exact test, and Student t test for parametric distrib- surgical site infections not observed in the larger
uted variables and Kruskal-Wallis for nonparametric cohort.
380 Wihbey et al Prophylactic Negative Pressure Wound Therapy OBSTETRICS & GYNECOLOGY
At the time of study initiation (April 2015), based infection, as predicted in the original sample size
on the current literature, we assumed an occurrence of calculation (20% superficial surgical site infection in
superficial surgical site infection of 20% of obese women with standard dressing and 10% in women
women undergoing cesarean delivery.4,9,10 We deter- with prophylactic negative pressure wound therapy),
mined that 400 women (200 prophylactic negative our study’s power to detect a difference between the
pressure wound therapy, 200 standard dressing) two interventions would be 29% at completion of
would need to be recruited to have an 80% power enrollment of our 400 participants. If we assumed that
to detect a 50% decrease in superficial surgical site the primary outcome in the remaining 244 women
infection (assuming P,.05). We anticipated that would be the same as prevalence observed in the first
enrollment across the two sites would take 24 months. 166 women who had already completed the study,
At the completion of the anticipated 2 years of our study’s power to detect a difference between the
recruitment, 166 women out of a planned 400 (42%) two interventions would be less than 0.1%. Therefore,
had been enrolled in the study. This was likely the the determination of the data safety monitoring board
result of the limitations of women’s ability to return was that continued enrollment to original recruitment
for device removal and incision evaluation 5–7 days targets was futile and the recommendation was made
after delivery (many had been transported to the ter- to halt further enrollment and disseminate our
findings.
tiary recruiting site and lived a long distance from this
site). As a result of this low enrollment, the study’s
data safety monitoring board recommended an RESULTS
unplanned interim analysis with futility calculation Women were recruited between January 5, 2015, and
to determine whether the study should continue. January 7, 2017. A total of 166 women were random-
We anticipated that to reach our original recruit- ized, 163 received their allocated treatment, and 161
ment goals, we would need to continue our study for (80 prophylactic negative pressure wound therapy and
34 additional months. If we assumed that observed 81 standard dressing) returned for their postoperative
outcomes in the remaining 244 women would wound assessment approximately 1 week after cesar-
develop the primary outcome, superficial surgical site ean delivery (Fig. 1). The two randomization groups
VOL. 132, NO. 2, AUGUST 2018 Wihbey et al Prophylactic Negative Pressure Wound Therapy 381
Group .32
Prophylactic negative pressure wound therapy 12 (60) 68 (48)
Standard dressing 8 (40) 73 (51)
Site .09
A 19 (95) 112 (79)
B 1 (5) 29 (21)
Maternal characteristics
Maternal age (y) 31.066 30.766 .85
Race .24
White 19 (95) 133 (99)
Black 1 (5) 0 (0)
Other 0 (0) 1 (1)
Ethnicity .23
Hispanic 1 (5) 1 (1)
Parity .66
1 9 (45) 43 (31)
2 6 (30) 53 (38)
3 4 (20) 36 (26)
4 or more 1 (5) 9 (6)
Gestational age (wk) .87
28 or less 0 (0) 4 (3)
Greater than 28–37 5 (28) 32 (25)
Greater than 37–42 13 (72) 93 (72)
Greater than 42 0 (0) 0 (0)
Gestational age (d) 261621 260624 .82
Prior cesarean deliveries .03
0 16 (80) 66 (47)
1 2 (10) 57 (40)
2 2 (10) 16 (11)
3 or more 0 (0) 2 (1)
BMI (kg/m2) 46.968 43.567 .06
BMI category (kg/m2) .02
35–40 3 (15) 58 (41)
Higher than 40 17 (85) 83 (59)
Preoperative serum hct (%) 34.866 30.2610 .04
Preoperative anemia (serum hct less than 36%) 9 (45) 101 (72) .02
Antenatal steroids 4 (20) 15 (11) .26
Diabetes mellitus .63
Type I diabetes mellitus 0 (0) 2 (2)
Type II diabetes mellitus 3 (16) 10 (8)
Gestation diabetes mellitus 3 (16) 27 (21)
Hypertension
Chronic hypertension 2 (10) 8 (6) .36
Gestational hypertension 1 (5) 8 (6) 1.00
Preeclampsia with severe features 2 (10) 13 (9) 1.00
Current smoker 3 (15) 23 (16) 1.00
Labor
Reason for admission labor and delivery .79
Spontaneous labor 12 (67) 83 (67)
Induction of labor 5 (28) 27 (22)
Scheduled cesarean delivery 1 (6) 14 (11)
Duration of rupture of membranes (min) 2726457 216 (425) .59
Duration of rupture of membranes (h) 1.00
Less than 18 18 (90) 127 (90)
18 or more 2 (10) 14 (10)
Chorioamnionitis present at the time of delivery 0 (0) 1 (1) 1.00
(continued )
382 Wihbey et al Prophylactic Negative Pressure Wound Therapy OBSTETRICS & GYNECOLOGY
Intraoperative variables
Fetal weight (g) 3,19261,088 3,1796971 .96
1-min Apgar score 6.563 7.262 .15
5-min Apgar score 8.661 8.461 .61
Operative time (min) 86.3628 80.7624 .33
Type of anesthesia .10
Spinal–epidural 16 (80) 129 (92)
General 4 (20) 11 (8)
Skin incision .21
Pfannenstiel 19 (100) 100 (89)
Vertical midline 0 (0) 13 (12)
Skin closure 1.00
Subcuticular 18 (95) 103 (92)
Staples 1 (5) 9 (8)
Estimated blood loss (mL) 9556309 9496289 .93
Postpartum hemorrhage (greater than 1,000 mL) 9 (45) 65 (46) 1.00
Intraoperative blood transfusion 0 (0) 3 (2) 1.00
Concomitant procedures 1.00
Tubal ligation 6 (30) 42 (30)
Peripartum hysterectomy 0 (0) 0 (0)
SSI, surgical site infection; BMI, body mass index; hct, hematocrit.
Data are n (%) or mean6SD.
were similar in regard to maternal characteristics and there were no differences in the occurrence of observed
intrapartum and intraoperative events (Tables 1 and 2). superficial surgical site infections in women using the
Twelve percent of women (20/161) completing prophylactic negative pressure wound therapy (21%
the 1-week incision check experienced superficial [4/19]) compared with women receiving standard dress-
surgical site infection. There were no statistically ings (20% [3/15], P..99).
significant differences in the occurrence of observed Risk factors for superficial surgical site infection
superficial surgical site infections between women are explored in Table 4. In addition to maternal BMI
using prophylactic negative pressure wound therapy category, number of prior cesarean deliveries and pre-
(12/80 [15%]) compared with women who received operative anemia (serum hematocrit less than 36%)
the standard dressing (8/81 [10%], P5.35; Table 3; were both associated with increased postcesarean
relative risk 1.52, 95% CI 0.66–3.52). Assuming that superficial surgical site infection (Table 4).
all women who were lost to follow-up developed There were no statistically significant differences
superficial surgical site infection, there still would observed for length of stay after delivery and breastfeed-
not have been a statistically significant difference in ing at the time of hospital discharge between women
the occurrence of superficial surgical site infection with prophylactic negative pressure wound therapy and
between groups (12/80 [15%] vs 13/86 [15%], P5.98). standard dressings. Fifteen percent of women (12/80)
There were no significant differences in the occur- with the prophylactic negative pressure wound therapy
rence of composite wound complications between device had it removed early: five women for local skin
women using prophylactic negative pressure wound irritation, six women because the pump stopped work-
therapy (25/80 [31%]) compared with women who ing, and one additional woman requested early removal.
received the standard dressing (24/81 [30%], P5.87).
In a subgroup analysis of the 71 women with BMIs of DISCUSSION
40 to 50, there were no statistically significant differences In this randomized controlled trial, we did not observe
observed in superficial surgical site infections in the a decrease in superficial surgical site infection after
women using the prophylactic negative pressure wound cesarean delivery in obese women with the use of
therapy (7/31 [23%]) compared with women receiving prophylactic negative pressure wound therapy. Even in
standard dressings (7/40 [18%], P5.77). In a subgroup a subgroup analysis of morbidly obese (BMI of 40 to 50)
analysis of the 34 women with BMIs higher than 50, and the most obese women (BMI higher than 50), who
VOL. 132, NO. 2, AUGUST 2018 Wihbey et al Prophylactic Negative Pressure Wound Therapy 383
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