Surgical Wound InfectionNCT02649543
Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures.
A study testing Primary Closure, Vacuum Assisted Closure and Delayed Primary Closure in people with Surgical Wound Infection, run by Eduardo Flores Villalba at 1 site in Mexico.
Trial summary
The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Primary Closure, Vacuum Assisted Closure and Delayed Primary Closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Dec 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.
Who cannot join
- Patient refusal to participate in the trial
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Escuela Nacional de Medicina, Tecnologico de Monterrey
Monterrey, Nuevo León, 76140
About this study
Official title: Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
Read the detailed description
The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.
- Conditions
- Surgical Wound Infection
- Being tested
- Primary Closure, Vacuum Assisted Closure, Delayed Primary Closure
- Keywords
- Surgical Wound Infection, Negative-Pressure Wound Therapy, Wound Closure Techniques, Laparotomy., Abdominal Wound Closure Techniques
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ClosureProcedure or surgery
A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. Subcutaneous tissue was approximated with Polyglycolic Acid 3-0, and the skin is sutured using Polypropylene 2-0.
Vacuum Assisted ClosureProcedure or surgery
A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia is closed with a continuous Polyglycolic Acid 0 suture. The VAC® system is then used, with change of dressings every 48 hrs. The wound is closed using Polypropylene 2-0 only after healthy granulation tissue and no signs of infection are present.
Delayed Primary ClosureProcedure or surgery
A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. The wound is left open for at least 7 days, after which closure with Polypropylene 2-0 takes place if considered suitable by a board certified surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure | Active comparator | Primary Closure is made after surgery. Receives: Procedure: Primary Closure |
| Delayed Primary Closure | Active comparator | Delayed Primary Closure is made after at least 7 days. Receives: Procedure: Delayed Primary Closure |
| Vacuum Assisted Closure | Active comparator | Vacuum Assisted Device is used in the wound. Receives: Procedure: Vacuum Assisted Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Wound Infection with each Wound Closure Technique
Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eduardo Flores Villalba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Flores Villalba, Tecnologico de Monterrey
- Investigators
- Gerardo Lozano Balderas, MD, Principal investigator, Escuela Nacional de Medicina, Tecnologico de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649543
- Sponsor's protocol ID
- ACAB-01
- Status last verified
- Jan 2016
- First submitted
- 25 Nov 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02649543
- Acronym / sponsor ID
- ACAB-01
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical Wound Infection, Negative-Pressure Wound Therapy, Wound Closure Techniques, Laparotomy., Abdominal Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eduardo Flores VillalbaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
Detailed description
The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Closure | Active comparator | Procedure: Primary ClosurePrimary Closure is made after surgery. |
| Delayed Primary Closure | Active comparator | Procedure: Delayed Primary ClosureDelayed Primary Closure is made after at least 7 days. |
| Vacuum Assisted Closure | Active comparator | Procedure: Vacuum Assisted ClosureVacuum Assisted Device is used in the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.
Key exclusion criteria (1 listed)
- Patient refusal to participate in the trial
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 |
|---|---|---|
| Primary ClosureA double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. Subcutaneous tissue was approximated with Polyglycolic Acid 3-0, and the skin is sutured using Polypropylene 2-0. | Procedure or surgery | Primary Closure |
| Vacuum Assisted ClosureA double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia is closed with a continuous Polyglycolic Acid 0 suture. The VAC® system is then used, with change of dressings every 48 hrs. The wound is closed using Polypropylene 2-0 only after healthy granulation tissue and no signs of infection are present. | Procedure or surgery | Vacuum Assisted Closure |
| Delayed Primary ClosureA double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. The wound is left open for at least 7 days, after which closure with Polypropylene 2-0 takes place if considered suitable by a board certified surgeon. | Procedure or surgery | Delayed Primary Closure |
Primary outcome
Incidence of Surgical Wound Infection with each Wound Closure Technique
Time frame: Two months
Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.
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 7 Jan 2016.
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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.
Gerardo Lozano Balderas, MD principal investigator
Escuela Nacional de Medicina, Tecnologico de Monterrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Closure, Vacuum Assisted Closure and Delayed Primary Closure in people with Surgical Wound Infection, run by Eduardo Flores Villalba at 1 site in Mexico.
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 1 inclusion and 1 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 7 Jan 2016. 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 Mexico. 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?
Incidence of Surgical Wound Infection with each Wound Closure Technique (time frame: Two months). 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 7 Jan 2016.