Surgical Site InfectionNCT05210556
Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery
An observational study of Surgical Site Infection and Surgical Complication, run by WellSpan Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Surgical Complication, Gynecologic Cancer
- What is being tested?
- Diagnosed with Surgical Site Infection
- How many people
- 778 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2021to 30 Jun 2024
- Phase
- Observational
- 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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had intra-abdominal surgery by a WellSpan gynecologic oncologist from 2019-2021 as identified by review of the surgical schedule.
Who may be able to join
- Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist
Who cannot join
- Unscheduled surgery
- Intraoperative consult by a WellSpan gynecologic oncologist
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.
Read the detailed description
This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.
- Being tested
- Diagnosed with Surgical Site Infection
- Keywords
- surgical site infection, gynecologic cancer
- 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.
Diagnosed with Surgical Site InfectionOther
As an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery
| Study group | Role | What they receive |
|---|---|---|
| No Antibiotic Bowel Prep | Patients who did not receive a preoperative antibiotic bowel preparation Receives: Other: Diagnosed with Surgical Site Infection | |
| Antibiotic Bowel Prep | Patients who did receive a preoperative antibiotic bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rates Associated with Antibiotic Bowel Prep
Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start22 Dec 2021
- Primary completion1 Feb 2022
- Study completion30 Jun 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eav Lim, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210556
- Sponsor's protocol ID
- 1847220-1
- Status last verified
- Apr 2024
- First submitted
- 13 Jan 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson RL, Glenny AM, Song F. Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001181. doi: 10.1002/14651858.CD001181.pub3.
PubMed 19160191Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.
PubMed 25607761Kalogera E, Van Houten HK, Sangaralingham LR, Borah BJ, Dowdy SC. Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies. Am J Obstet Gynecol. 2020 Aug;223(2):231.e1-231.e12. doi: 10.1016/j.ajog.2020.02.035. Epub 2020 Feb 26.
PubMed 32112733Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.
PubMed 4743867Kennedy K, Gaertner-Otto J, Lim E. Reduction in deep organ-space infection in gynecologic oncology surgery with use of oral antibiotic bowel preparation: a retrospective cohort analysis. J Osteopath Med. 2024 Oct 9;125(5):269-276. doi: 10.1515/jom-2024-0099. eCollection 2025 May 1.
PubMed 39376031
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery
- ClinicalTrials.gov ID
- NCT05210556
- Acronym / sponsor ID
- 1847220-1
- Keywords
- surgical site infection, gynecologic cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Jan 2022 (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.
The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.
Detailed description
This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Antibiotic Bowel Prep | – | Other: Diagnosed with Surgical Site InfectionPatients who did not receive a preoperative antibiotic bowel preparation |
| Antibiotic Bowel Prep | – | –Patients who did receive a preoperative antibiotic bowel preparation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had intra-abdominal surgery by a WellSpan gynecologic oncologist from 2019-2021 as identified by review of the surgical schedule.
Key inclusion criteria (1 listed)
- Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist
Key exclusion criteria (2 listed)
- Unscheduled surgery
- Intraoperative consult by a WellSpan gynecologic oncologist
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 |
|---|---|---|
| Diagnosed with Surgical Site InfectionAs an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery | Other | No Antibiotic Bowel Prep |
Primary outcome
Surgical Site Infection Rates Associated with Antibiotic Bowel Prep
Time frame: 2019-2021
Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation
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 28 Mar 2025.
- Background: PubMed 19160191Nelson RL, Glenny AM, Song F. Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001181. doi: 10.1002/14651858.CD001181.pub3.
- Background: PubMed 25607761Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.
- Background: PubMed 32112733Kalogera E, Van Houten HK, Sangaralingham LR, Borah BJ, Dowdy SC. Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies. Am J Obstet Gynecol. 2020 Aug;223(2):231.e1-231.e12. doi: 10.1016/j.ajog.2020.02.035. Epub 2020 Feb 26.
- Background: PubMed 4743867Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.
- Derived from this study: PubMed 39376031Kennedy K, Gaertner-Otto J, Lim E. Reduction in deep organ-space infection in gynecologic oncology surgery with use of oral antibiotic bowel preparation: a retrospective cohort analysis. J Osteopath Med. 2024 Oct 9;125(5):269-276. doi: 10.1515/jom-2024-0099. eCollection 2025 May 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Surgical Complication, run by WellSpan Health 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 1 inclusion and 2 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 28 Mar 2025. 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?
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?
Surgical Site Infection Rates Associated with Antibiotic Bowel Prep (time frame: 2019-2021). 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 NCT05210556, 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 28 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.