Surgical Site InfectionNCT03500055
Abdominal Closure Bundle to Reduce Surgical Site Infection in Patients Undergoing C-sections. Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
A study testing Abdominal Closure Bundle in people with Surgical Site Infection and Cesarean Section; Infection, run by Abington Memorial Hospital at 1 site in United States.
Trial summary
This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection, Cesarean Section; Infection
- What is being tested?
- Abdominal Closure Bundle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to Dec 2019
- 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
- 18 years or older
- Greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study.
- Patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section are also included in the study.
Who cannot join
- Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
- SOAT (Surgical Operative Assist Team) cesarean sections
- Gestational age < 34 weeks for any reason
- Preterm premature rupture of membranes from antepartum unit
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Abington Hospital-Jefferson Health
Abington, Pennsylvania, 19001
Shaina F Bruce, MD, 215-481-7915, shaina.bruce@jefferson.edu
Preethi Rajendran, MD, 215-481-7884, preethi.rajendran@jefferson.edu
About this study
Official title: Does Implementation of an Abdominal Closure Bundle in Patients Undergoing Scheduled Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and skin. Patients will be randomized to either abdominal closure bundle or normal operative procedure. Primary outcome is surgical site infection within 30 days of procedure.
Read the detailed description
All patients, aged 18 years or older, greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study. Scheduled cesarean sections include all routine cesarean sections- whether receiving spinal or general anesthesia, as well as patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section.
The following patients will be excluded from our study:
- Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
- SOAT (Surgical Operative Assist Team) cesarean sections
- Gestational age < 34 weeks for any reason
- Preterm premature rupture of membranes from antepartum unit
As there are no published prospective trials abdominal closure bundles in cesarean sections, sample size calculations were completed using a recently published meta-analysis of multiple retrospective studies.4 These studies investigated various surgical site reduction techniques as applied to cesarean sections. Using this data, which shows an average pre-intervention SSI rate of 6% and post-reduction SSI rate of 2%, to detect a statistically significant reduction, we will need to enroll approximately 850 patients.
Patients will be randomly assigned to receive either normal operative procedure or the closing bundle through a randomized process. Simple randomization in a 1:1 ratio will be completed via Microsoft Excel. Group assignments will be placed in sealed opaque envelopes which will be located on the labor and delivery unit. The envelope will be opened by the resident physician or advanced practice professional who will be assisting with the cesarean section on arrival to the operating room. This will allow the scrub tech to prepare the closing tray prior to the start of the procedure if indicated.
All patients will receive pre-operative antibiotics, chlorhexidine abdominal preparation, thirty second betadine vaginal preparation, hair removal by clippers at the operative site, lower extremity forced air warmer, subcutaneous tissue closure >2cm, subcuticular skin closure, and removal of surgical bandage on post-operative day 2. The abdominal closure bundle includes changing of the surgical gown and gloves, repeat surgical scrub, and usage of new surgical instruments, light handles, suction, and bovie tip for closure of fascia, subcutaneous tissue, and skin. Given the nature of the intervention, the surgeon and patient will not be blinded to group assignment.
- Being tested
- Abdominal Closure Bundle
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Closure BundleProcedure or surgery
Surgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Closure Bundle | Experimental | Surgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin. Receives: Procedure: Abdominal Closure Bundle |
| Control | No intervention | Normal operative procedure. The abdominal closure bundle will not be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Definitions per 2017 CDC definitions
Measured: Within 30 days of procedure.
Secondary outcomes (1)
Risk factors for surgical site infection
Will collect demographic, obstetrical, and surgical characteristics and determine specific risk factors for surgical site infection in these patients.
Measured: Within 30 days of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Site 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
- Model description
- Single center, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaina Bruce, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500055
- Sponsor's protocol ID
- 18-016
- Status last verified
- Jul 2018
- First submitted
- 9 Apr 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pellegrini JE, Toledo P, Soper DE, Bradford WC, Cruz DA, Levy BS, Lemieux LA. Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery. J Obstet Gynecol Neonatal Nurs. 2017 Jan-Feb;46(1):100-113. doi: 10.1016/j.jogn.2016.10.003. Epub 2016 Dec 8.
PubMed 27955845Schiavone MB, Moukarzel L, Leong K, Zhou QC, Afonso AM, Iasonos A, Roche KL, Leitao MM Jr, Chi DS, Abu-Rustum NR, Zivanovic O. Surgical site infection reduction bundle in patients with gynecologic cancer undergoing colon surgery. Gynecol Oncol. 2017 Oct;147(1):115-119. doi: 10.1016/j.ygyno.2017.07.010. Epub 2017 Jul 19.
PubMed 28734498Lachiewicz MP, Moulton LJ, Jaiyeoba O. Pelvic surgical site infections in gynecologic surgery. Infect Dis Obstet Gynecol. 2015;2015:614950. doi: 10.1155/2015/614950. Epub 2015 Feb 18.
PubMed 25788822Carter EB, Temming LA, Fowler S, Eppes C, Gross G, Srinivas SK, Macones GA, Colditz GA, Tuuli MG. Evidence-Based Bundles and Cesarean Delivery Surgical Site Infections: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):735-746. doi: 10.1097/AOG.0000000000002249.
PubMed 28885421Bruce SF, Carr DN, Burton ER, Sorosky JI, Shahin MS, Naglak MC, Edelson MI. Implementation of an abdominal closure bundle to reduce surgical site infection in patients on a gynecologic oncology service undergoing exploratory laparotomy. Gynecol Oncol. 2018 Jun;149(3):560-564. doi: 10.1016/j.ygyno.2018.03.045. Epub 2018 Mar 14.
PubMed 29548786
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Implementation of an Abdominal Closure Bundle in Patients Undergoing Scheduled Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03500055
- Acronym / sponsor ID
- 18-016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Apr 2018 (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 is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and skin. Patients will be randomized to either abdominal closure bundle or normal operative procedure. Primary outcome is surgical site infection within 30 days of procedure.
Detailed description
All patients, aged 18 years or older, greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study. Scheduled cesarean sections include all routine cesarean sections- whether receiving spinal or general anesthesia, as well as patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section.
The following patients will be excluded from our study:
- Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
- SOAT (Surgical Operative Assist Team) cesarean sections
- Gestational age < 34 weeks for any reason
- Preterm premature rupture of membranes from antepartum unit
As there are no published prospective trials abdominal closure bundles in cesarean sections, sample size calculations were completed using a recently published meta-analysis of multiple retrospective studies.4 These studies investigated various surgical site reduction techniques as applied to cesarean sections. Using this data, which shows an average pre-intervention SSI rate of 6% and post-reduction SSI rate of 2%, to detect a statistically significant reduction, we will need to enroll approximately 850 patients.
Patients will be randomly assigned to receive either normal operative procedure or the closing bundle through a randomized process. Simple randomization in a 1:1 ratio will be completed via Microsoft Excel. Group assignments will be placed in sealed opaque envelopes which will be located on the labor and delivery unit. The envelope will be opened by the resident physician or advanced practice professional who will be assisting with the cesarean section on arrival to the operating room. This will allow the scrub tech to prepare the closing tray prior to the start of the procedure if indicated.
All patients will receive pre-operative antibiotics, chlorhexidine abdominal preparation, thirty second betadine vaginal preparation, hair removal by clippers at the operative site, lower extremity forced air warmer, subcutaneous tissue closure >2cm, subcuticular skin closure, and removal of surgical bandage on post-operative day 2. The abdominal closure bundle includes changing of the surgical gown and gloves, repeat surgical scrub, and usage of new surgical instruments, light handles, suction, and bovie tip for closure of fascia, subcutaneous tissue, and skin. Given the nature of the intervention, the surgeon and patient will not be blinded to group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Abdominal Closure Bundle | Experimental | Procedure: Abdominal Closure BundleSurgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin. |
| Control | No intervention | –Normal operative procedure. The abdominal closure bundle will not be used. |
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)
- 18 years or older
- Greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study.
- Patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section are also included in the study.
Key exclusion criteria (4 listed)
- Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
- SOAT (Surgical Operative Assist Team) cesarean sections
- Gestational age < 34 weeks for any reason
- Preterm premature rupture of membranes from antepartum unit
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 |
|---|---|---|
| Abdominal Closure BundleSurgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin | Procedure or surgery | Abdominal Closure Bundle |
Primary outcome
Surgical Site Infection
Time frame: Within 30 days of procedure.
Definitions per 2017 CDC definitions
1 secondary outcome
Risk factors for surgical site infection
Time frame: Within 30 days of procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 27955845Pellegrini JE, Toledo P, Soper DE, Bradford WC, Cruz DA, Levy BS, Lemieux LA. Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery. J Obstet Gynecol Neonatal Nurs. 2017 Jan-Feb;46(1):100-113. doi: 10.1016/j.jogn.2016.10.003. Epub 2016 Dec 8.
- Background: PubMed 28734498Schiavone MB, Moukarzel L, Leong K, Zhou QC, Afonso AM, Iasonos A, Roche KL, Leitao MM Jr, Chi DS, Abu-Rustum NR, Zivanovic O. Surgical site infection reduction bundle in patients with gynecologic cancer undergoing colon surgery. Gynecol Oncol. 2017 Oct;147(1):115-119. doi: 10.1016/j.ygyno.2017.07.010. Epub 2017 Jul 19.
- Background: PubMed 25788822Lachiewicz MP, Moulton LJ, Jaiyeoba O. Pelvic surgical site infections in gynecologic surgery. Infect Dis Obstet Gynecol. 2015;2015:614950. doi: 10.1155/2015/614950. Epub 2015 Feb 18.
- Background: PubMed 28885421Carter EB, Temming LA, Fowler S, Eppes C, Gross G, Srinivas SK, Macones GA, Colditz GA, Tuuli MG. Evidence-Based Bundles and Cesarean Delivery Surgical Site Infections: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):735-746. doi: 10.1097/AOG.0000000000002249.
- Background: PubMed 29548786Bruce SF, Carr DN, Burton ER, Sorosky JI, Shahin MS, Naglak MC, Edelson MI. Implementation of an abdominal closure bundle to reduce surgical site infection in patients on a gynecologic oncology service undergoing exploratory laparotomy. Gynecol Oncol. 2018 Jun;149(3):560-564. doi: 10.1016/j.ygyno.2018.03.045. Epub 2018 Mar 14.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Closure Bundle in people with Surgical Site Infection and Cesarean Section; Infection, run by Abington Memorial Hospital at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaina F Bruce, MD (215-481-7915, shaina.bruce@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: Within 30 days of procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500055, which also lists 5 linked publications.
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 5 Jul 2018.