Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05748743
Other study ID # CK62721303
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2020
Est. completion date February 25, 2021

Study information

Verified date February 2023
Source Hung Vuong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.


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.


Recruitment information / eligibility

Status Completed
Enrollment 678
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
glove changing
Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery

Locations

Country Name City State
Vietnam Hung Vuong hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
Hung Vuong Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound complications Seroma, hematoma, wound separation, and wound infection Within 4 weeks after surgery
Secondary Surgical site infection Fever, swelling, redness, and pain surrounding the incisional area Within 4 weeks after surgery
See also
  Status Clinical Trial Phase
Completed NCT01698372 - Negative Pressure Dressing After Saphenous Vein Harvest Phase 1
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Terminated NCT03148496 - Tissue Reinforcement of Incisional Closure Among High Risk Patients N/A
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Completed NCT05142956 - Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
Recruiting NCT03527433 - Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques N/A
Completed NCT03477682 - Postoperative Management of Groin Flaps for Vascular Coverage N/A
Not yet recruiting NCT02967627 - VAC Dressings for Colorectal Resections N/A
Terminated NCT02838017 - Tissue Adhesive vs. Sterile Strips After Cesarean Delivery N/A
Completed NCT04735133 - The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery N/A
Completed NCT03942575 - The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy N/A
Not yet recruiting NCT06191159 - Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions N/A
Terminated NCT02355691 - Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty N/A
Completed NCT02128997 - PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population N/A
Completed NCT01977612 - Randomized Clinical Trial of Skin Closure With Staples Versus Suture Phase 2
Completed NCT03061903 - Closed Incision Negative Pressure Therapy vs Standard of Care N/A
Recruiting NCT03948412 - Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant N/A