Wound Complication
Conditions
Keywords
Complications, Glove changing, Eesarean surgery, Infections, Vietnam
Brief summary
This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.
Detailed description
In Vietnam, the rate of Cesarean section (CS) is very high, ranging from 40-50%. Despite that, there are very limited publications concerning the risk factors, complications, and management of surgical site infection (SSI) following CS. Our study is the first to investigate the effectiveness of glove changing in reducing the incidence of post-operative infections in Vietnam. Specifically, the aims of this study 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.
Interventions
PROCEDUREglove changing
Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery
Sponsors
Hung Vuong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, and outcomes assessor are blind to the intervention group assignment.The only people that were unmasked were the surgical team.
Intervention model description
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 cesarean surgery. Aim 2 includes patients who will not have glove changed prior to abdominal closure during cesarean surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. Clinic visits are performed at 2 time points. 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 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women were 18 years old or higher; * pregnant women had cesarean surgery performed at Hung Vuong hospital; * pregnant women lived close to Ho Chi Minh city and agreed to return for postpartum care one-month post-surgery.
Exclusion criteria
* pregnant women had fever during labor; * pregnant women had systemic infectious conditions; * pregnant women had surgical site infection SSI or sexually infectious conditions; * pregnant women had 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound complications | Within 4 weeks after surgery | Seroma, hematoma, wound separation, and wound infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | Within 4 weeks after surgery | Fever, swelling, redness, and pain surrounding the incisional area |
Countries
Vietnam
Outcome results
None listed