Wound ComplicationC-SITNCT01897376
Cesarean Skin Incision Trial
A study testing Pfannenstiel incision and vertical skin incision in people with Wound Complication, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Complication
- What is being tested?
- Pfannenstiel incision and vertical skin incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jun 2017
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
- Age 18-50 years
- BMI of 40 kg/m2 or more
Who cannot join
- Underlying infection such as chorioamnionitis
- Rupture of membranes over 18 hours prior to cesarean section ,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UTMB
Galveston, Texas, 77555
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
About this study
Official title: The Comparative Effectiveness of Pfannenstiel Versus Vertical Skin Incision in Preventing Wound Complications After Cesarean Delivery in Morbidly Obese Women: a Randomized Clinical Trial.
The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient.
Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.
- Conditions
- Wound Complication
- Being tested
- Pfannenstiel incision, vertical skin incision
- Keywords
- wound, infection, cesarean delivery, obesity
- Medical subject headings
- Wounds and Injuries, Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfannenstiel incisionProcedure or surgery
Pfannenstiel incision at time of cesarean section
vertical skin incisionProcedure or surgery
vertical skin incision at time of cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Pfannenstiel incision | Other | Not described Receives: Procedure: Pfannenstiel incision |
| vertical skin incision | Other | Not described Receives: Procedure: vertical skin incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite wound complication
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
Measured: 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston
- Responsible party
- Principal investigator, Caroline Carter Marrs, MD, The University of Texas Health Science Center, Houston
- Investigators
- Caroline C Marrs, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897376
- Sponsor's protocol ID
- C-SIT
- Acronym
- C-SIT
- Status last verified
- Jun 2017
- First submitted
- 8 Jul 2013
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marrs C, Blackwell S, Hester A, Olson G, Saade GR, Faro J, Pedroza C, Sibai B. Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial. Am J Perinatol. 2019 Jan;36(1):97-104. doi: 10.1055/s-0038-1667287. Epub 2018 Jul 30.
PubMed 30060292
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Pfannenstiel Versus Vertical Skin Incision in Preventing Wound Complications After Cesarean Delivery in Morbidly Obese Women: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01897376
- Acronym / sponsor ID
- C-SIT / C-SIT
- Conditions
- Wound Complication
- Keywords
- wound, infection, cesarean delivery, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston
- Study start
- Jul 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jul 2013 (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 determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient.
Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pfannenstiel incision | Other | Procedure: Pfannenstiel incision |
| vertical skin incision | Other | Procedure: vertical skin incision |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
- Age 18-50 years
- BMI of 40 kg/m2 or more
Key exclusion criteria (2 listed)
- Underlying infection such as chorioamnionitis
- Rupture of membranes over 18 hours prior to cesarean section ,
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 |
|---|---|---|
| Pfannenstiel incisionPfannenstiel incision at time of cesarean section | Procedure or surgery | Pfannenstiel incision |
| vertical skin incisionvertical skin incision at time of cesarean section | Procedure or surgery | vertical skin incision |
Primary outcome
composite wound complication
Time frame: 6 weeks post-op
includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations
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 Jul 2017.
- Derived from this study: PubMed 30060292Marrs C, Blackwell S, Hester A, Olson G, Saade GR, Faro J, Pedroza C, Sibai B. Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial. Am J Perinatol. 2019 Jan;36(1):97-104. doi: 10.1055/s-0038-1667287. Epub 2018 Jul 30.
Related trials for Wound Complication
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
RecruitingPhase 2
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Metastatic Renal Cell Carcinoma ( mRCC), OligoProgressive Metastatic Disease
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.
Caroline C Marrs, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pfannenstiel incision and vertical skin incision in people with Wound Complication, run by The University of Texas Health Science Center, Houston at 2 sites 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 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
composite wound complication (time frame: 6 weeks post-op). 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 NCT01897376, which also lists 1 linked publication.
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 Jul 2017.