Effectiveness of Glove Changing in Reducing Wound-related... | NCT05748743

Studies
Effectiveness of Glove Changing in Reducing Wound-related Complications

NCT05748743

Sponsor

Hung Vuong Hospital

Status

Completed

Last Update Posted

Mar 2, 2023Actual

Enrollment

678Actual

Phase

Not Applicable

Conditions

Wound Complication

Interventions

glove changing

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2020Actual

Primary Completion Date

Feb 25, 2021Actual

Completion Date

Feb 25, 2021Actual

First Submitted Date

Feb 18, 2023

First Submission Date that Met QC Criteria

Feb 18, 2023

First Posted Date

Mar 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

678Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glove change group	Experimental	The surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia	Procedure: glove changing
Usual care group	No Intervention	The surgical gloves were not changed before abdominal closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glove changing	Procedure	Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound complications	Seroma, hematoma, wound separation, and wound infection	Within 4 weeks after surgery

Secondary Outcomes

Measure	Description	Time Frame
Surgical site infection	Fever, swelling, redness, and pain surrounding the incisional area	Within 4 weeks after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

We only recruited pregnant women to participate in this study

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tuyet Hoang, Doctor	Hung Vuong Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hung Vuong hospital		Ho Chi Minh City			Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 14, 2020	Feb 18, 2023	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

Triple

Masking Description

Participants, investigators, and outcomes assessor are blind to the intervention group assignment.The only people that were unmasked were the surgical team.

Who Masked

ParticipantInvestigatorOutcomes Assessor