Surgical Site Infection in Obese Women Undergoing C-sectionSSINCT01194115
Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery
A study testing cephalexin & metronidazole in people with Surgical Site Infection in Obese Women Undergoing C-section, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Surgical Site Infection in Obese Women Undergoing C-section
- What is being tested?
- cephalexin & metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI > 30kg/m*2
- Delivery via cesarean section
- consent to participate
- age 13 or older
Who cannot join
- known immunodeficiency syndromes
- non-English speaking
- known allergy to cephalosporins or metronidazole
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.
Read the detailed description
We propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection. This study is to be conducted by the Department of Obstetrics at University Hospital. The intervention being studied will be the continuation of cephalexin and metronidazole for 48 hours. The primary outcome measure will be the development of infectious morbidity, including wound infection and endometritis, in the postoperative period.
In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA filtration and positive air pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery as well as general OR traffic will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An antimicrobial, adhesive drape will be used. Prior to skin incision, cefazolin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at University Hospital. Patients with an elevated BMI > 30 kg/m2 who undergo cesarean section will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.
- Being tested
- cephalexin & metronidazole, placebo
- Keywords
- surgical site infection, obesity, pregnancy, cesarean section, cesarean delivery
- Medical subject headings
- Surgical Wound Infection, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalexin & metronidazoleDrug
Also called Keflex & Flagyl
cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
placeboDrug
placebo representing standard of care
| Study group | Role | What they receive |
|---|---|---|
| Cephalexin and metronidazole | Experimental | 500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses Receives: Drug: cephalexin & metronidazole |
| Placebo/standard of care | Placebo comparator | Placebo pills per oral every 8 hours for total of 6 doses Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Measured: 6weeks post partum
Secondary outcomes (1)
Febrile morbidity; Urinary tract infection; Endometritis
Measured: 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection in Obese Women Undergoing C-sectionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Maxwell, Ph.D., University of Cincinnati
- Investigators
- Carri Warshak, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194115
- Sponsor's protocol ID
- Surgical Site Infection C-Sect
- Acronym
- SSI
- Status last verified
- Nov 2011
- First submitted
- 1 Sep 2010
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hofmeyr GJ, Smaill FM. WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000933. doi: 10.1002/14651858.CD000933.pub2.
PubMed 20091509Meyer NL, Hosier KV, Scott K, Lipscomb GH. Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5. doi: 10.1097/01.SMJ.0000060570.51934.14.
PubMed 14570343Robinson HE, O'Connell CM, Joseph KS, McLeod NL. Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64. doi: 10.1097/01.AOG.0000188387.88032.41.
PubMed 16319263Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M. Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.
PubMed 6535654Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW. Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.
PubMed 18771992Valent AM, DeArmond C, Houston JM, Reddy S, Masters HR, Gold A, Boldt M, DeFranco E, Evans AT, Warshak CR. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1026-1034. doi: 10.1001/jama.2017.10567.
PubMed 28975304
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01194115
- Acronym / sponsor ID
- SSI / Surgical Site Infection C-Sect
- Keywords
- surgical site infection, obesity, pregnancy, cesarean section, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- First posted
- 2 Sep 2010 (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 purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.
Detailed description
We propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection. This study is to be conducted by the Department of Obstetrics at University Hospital. The intervention being studied will be the continuation of cephalexin and metronidazole for 48 hours. The primary outcome measure will be the development of infectious morbidity, including wound infection and endometritis, in the postoperative period.
In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA filtration and positive air pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery as well as general OR traffic will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An antimicrobial, adhesive drape will be used. Prior to skin incision, cefazolin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at University Hospital. Patients with an elevated BMI > 30 kg/m2 who undergo cesarean section will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cephalexin and metronidazole | Experimental | Drug: cephalexin & metronidazole500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses |
| Placebo/standard of care | Placebo comparator | Drug: placeboPlacebo pills per oral every 8 hours for total of 6 doses |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- BMI > 30kg/m*2
- Delivery via cesarean section
- consent to participate
- age 13 or older
Key exclusion criteria (3 listed)
- known immunodeficiency syndromes
- non-English speaking
- known allergy to cephalosporins or metronidazole
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 |
|---|---|---|
| cephalexin & metronidazoleAlso: Keflex & Flagylcephalexin at 500 mg per oral every 8 hours for a total of 6 doses | Drug | Cephalexin and metronidazole |
| placeboplacebo representing standard of care | Drug | Placebo/standard of care |
Primary outcome
Surgical site infection
Time frame: 6weeks post partum
1 secondary outcome
Febrile morbidity; Urinary tract infection; Endometritis
Time frame: 6 weeks post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
- Background: PubMed 20091509Hofmeyr GJ, Smaill FM. WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000933. doi: 10.1002/14651858.CD000933.pub2.
- Background: PubMed 14570343Meyer NL, Hosier KV, Scott K, Lipscomb GH. Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5. doi: 10.1097/01.SMJ.0000060570.51934.14.
- Background: PubMed 16319263Robinson HE, O'Connell CM, Joseph KS, McLeod NL. Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64. doi: 10.1097/01.AOG.0000188387.88032.41.
- Background: PubMed 6535654Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M. Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.
- Background: PubMed 18771992Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW. Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.
- Derived from this study: PubMed 28975304Valent AM, DeArmond C, Houston JM, Reddy S, Masters HR, Gold A, Boldt M, DeFranco E, Evans AT, Warshak CR. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1026-1034. doi: 10.1001/jama.2017.10567.
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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.
Carri Warshak, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cephalexin & metronidazole in people with Surgical Site Infection in Obese Women Undergoing C-section, run by University of Cincinnati 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 4 inclusion and 3 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 11 Nov 2011. 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. Some participants in this study may receive a placebo. 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?
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?
Surgical site infection (time frame: 6weeks post partum). 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 NCT01194115, which also lists 6 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 11 Nov 2011.