Wound ComplicationNCT05748743
Effectiveness of Glove Changing in Reducing Wound-related Complications
A study testing glove changing in people with Wound Complication, run by Hung Vuong Hospital at 1 site in Vietnam.
Trial summary
This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Complication
- What is being tested?
- glove changing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteVietnam
- Study dates
- 18 Dec 2020to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam
This study aimed to investigate the effectiveness of glove changing in reducing complications of cesarean deliveries in Vietnam.
Read the 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.
- Conditions
- Wound Complication
- Being tested
- glove changing
- Keywords
- Complications, Glove changing, Eesarean surgery, Infections, Vietnam
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glove changingProcedure or surgery
Surgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery
| Study group | Role | What they receive |
|---|---|---|
| Glove change group | Experimental | The surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia Receives: Procedure: glove changing |
| Usual care group | No intervention | The surgical gloves were not changed before abdominal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
Seroma, hematoma, wound separation, and wound infection
Measured: Within 4 weeks after surgery
Secondary outcomes (1)
Surgical site infection
Fever, swelling, redness, and pain surrounding the incisional area
Measured: Within 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start18 Dec 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tri Bao Nguyen, Hung Vuong Hospital
- Investigators
- Tuyet Hoang, Doctor, Study director, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748743
- Sponsor's protocol ID
- CK62721303
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Randomized Control Trial to Evaluate the Effectiveness of Glove Changing in Reducing Wound-related Complications Following Cesarean Section in Vietnam
- ClinicalTrials.gov ID
- NCT05748743
- Acronym / sponsor ID
- CK62721303
- Conditions
- Wound Complication
- Keywords
- Complications, Glove changing, Eesarean surgery, Infections, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Glove change group | Experimental | Procedure: glove changingThe surgical gloves were changed prior to closure of the peritoneum or closure of the abdominal fascia |
| Usual care group | No intervention | –The surgical gloves were not changed before abdominal closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glove changingSurgical gloves were changed prior to abdominal closure during Cesarean section to evaluate its effectiveness in reducing wound complications after surgery | Procedure or surgery | Glove change group |
Primary outcome
Wound complications
Time frame: Within 4 weeks after surgery
Seroma, hematoma, wound separation, and wound infection
1 secondary outcome
Surgical site infection
Time frame: Within 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuyet Hoang, Doctor study director
Hung Vuong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glove changing in people with Wound Complication, run by Hung Vuong Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound complications (time frame: Within 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.