Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam
Phase: NA
Conditions: Wound Complication
Sponsor: Hung Vuong Hospital

 
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STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
Using a randomized control trial to evaluate the effectiveness of glove changing in reducing 
wound-related complications following cesarean section in Vietnam 
 
 
Principle investigator  
 
Tri Bao Nguyen, MD 
 
 
 
 
 
Obstetrician – Gynecologist 
 
 
 
 
 
Hung Vuong hospital  
 
 
 
 
 
Ho Chi Minh city, Vietnam 
 
Protocol identification number  
CK62721303 (dated September 14, 2020) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Abbreviations 
 
CS 
 
Cesarean section 
SSI 
 
Surgical site infection 
CPR 
 
Cardiopulmonary resuscitation 
ASA  
American Society of Anesthesiologists 
NYHA  
New York Heart Association  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of contents  
 
1. Introduction ………………………………………………………………………… 
4 
2. Study design ……………………………………………………………………….. 
4 
3. Aims and objectives ………………………………………………………………... 
6  
4. Outcomes …….…………………………………………………………………….. 
6 
5. Populations and subgroups to be analyzed …………………………………………. 
6 
6. Analyses ……………………………………………………………………………. 
6 
7. References  …………………………………………………………………………. 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. Introduction 
The aim of this study is to investigate the effect of glove changing on wound complications after 
cesarean surgery in Vietnam. We hypothesize that changing gloves prior to abdominal closure 
reduces the incidence of infectious complications following cesarean surgery. 
 
2. Study design  
Study subjects will be recruited from December 2020 to February 2021 at Hung Vuong hospital, 
Ho Chi Minh city, Vietnam. Inclusion criteria for participants in this study include pregnant 
women who are 18 years old or higher; who have CS performed at Hung Vuong hospital; and 
who live close to Ho Chi Minh city and agree to return for postpartum care one-month post-
surgery. Exclusion criteria include pregnant women who have fever during labor; who have 
systemic infectious conditions; who have surgical site infection SSI or sexually infectious 
conditions; who have ongoing internal conditions such as pre-eclampsia, severe anemia, American 
Society of Anesthesiologists (ASA) ≥ 3, New York Heart Association (NYHA) class 3 or above, 
pulmonary edema, or severe asthma. Data collection will be stopped when pregnant women require 
cardiopulmonary resuscitation (CPR) or have damaged pelvic organs during CS; when they need 
extra surgery after CS; or when the surgical team has double gloving or the gloves get punctured 
during surgery. 
The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who 
will have glove changed prior to abdominal closure during CS. Aim 2 includes patients who will 
not have glove changed prior to abdominal closure during CS. All patients are randomized using 
computer-generated sequences with allocation ratio 1:1. Clinic visits are performed at 2 time 
points, unless emergency check-up is recommended after hospital discharge. Visit 1 is at 2-3 days 
post-surgery and visit 2 is at 30 ± 2 days post-surgery where primary and secondary outcomes are 
measured. The study is concluded when we finish the second data collection or when patients are 
discharged from the hospital after a required immediate check-up. Patients who do not return for 
postpartum care will be considered lost to follow up. The study design is visualized in Figure 1 
below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Figure 1: The CONSORT flow diagram of the study  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample size calculation  
The sample size is calculated based on the following formula: 
𝑛=
# 𝑍!"#
$&2𝑃(1 −𝑃) + Z!"%&𝑃!(1 −𝑃!) + 𝑃$(1 −𝑃$)/
$
(𝑃! −𝑃$)$
    
Where: 
n: required minimum sample size in each group 
P1: rate of superficial SSI in group 1 (i.e., glove change group) 
P2: rate of superficial SSI in group 2 (i.e., control, or usual care group) 
𝑃= P1 + P2
2
 
α: type I error, α = 0,05 à Z1- α/2 = 1,96 
β: type II error, β = 0,15 (statistical power = 0,85) à Z1- β = 1,04 
Based on the results from Scrafford’s group where they reported the rates of superficial SSI in the 
glove change group and the usual care group were 6.4% and 13.6%, respectively [1], we will 
calculate the sample size for each group. In order to achieve the statistical power of 0.85, 
the required minimum sample size in each group is 310. To account for 5% of the sample lost 

 
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during the study, the sample size in each group is increased to 327 based on the calculation 
310/0.95=327. Thus, the required minimum sample size for both groups in our study will 
be 327*2=654. 
 
3. Aims and objectives 
The aims are 1) to evaluate whether changing gloves during CS reduces complications and SSI, 
and 2) to identify other factors that are associated with complications and SSI. 
4. Outcomes 
The primary outcomes of interest are any wound complications occurring after the surgery, 
including seroma, hematoma, wound separation, and wound infection. Secondary outcomes are 
any signs of SSI, including fever, swelling, redness, and pain surrounding the incisional area. The 
outcomes will be evaluated during clinic visits by qualified medical practitioners who are blind to 
the intervention group assignment. 
 
5. Populations and subgroups to be analyzed 
Populations: intention-to-treat 
Subgroups: the glove change and usual care group. These 2 subgroups will be analyzed using 
intention-to-treat populations.  
 
6. Analyses  
Data will be analyzed using Stata 16 (StataCorp LLC, College Station, TX). Normally distributed 
data will be expressed as mean ± standard deviation, while non-normally distributed data will be 
shown as medians with interquartile ranges. T-test for normally distributed continuous variables 
and Mann-Whitney-U test for non-normally distributed continuous variables will be used to 
compare between groups. Categorical variables will be reported as absolute numbers and 
percentages; the Chi-square test or Fisher's exact test will be utilized for comparison. A p-value of 
<0.05 will be considered statistically significant. Multiple logistics regression analysis will be 
performed to identify factors affecting the superficial incisional complications. 
 
7.    References 
[1] J. D. Scrafford, B. Reddy, C. Rivard, and R. I. Vogel, “Effect of intra-operative glove changing 
during cesarean section on post-operative complications: a randomized controlled trial,” Arch 
Gynecol Obstet, vol. 297, no. 6, pp. 1449–1454, Jun. 2018, doi: 10.1007/s00404-018-4748-y.