C.Delivery; Penetration, Pregnant Uterus, by InstrumentNCT02549131
Cesarean Wound Closure in Women With BMI 40 or Greater
A study testing Randomizing to Suture or Staple closure of Cesarean section in people with C.Delivery; Penetration, Pregnant Uterus, by Instrument and Obesity, run by Pediatrix at 2 sites in United States.
Trial summary
The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- C.Delivery; Penetration, Pregnant Uterus, by Instrument, Obesity
- What is being tested?
- Randomizing to Suture or Staple closure of Cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Jan 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman
- Time to approach and consent the patient prior to undergoing cesarean delivery
- Able to give informed consent, include age 18 or greater and ability to read and understand English
- BMI of 40 or greater on most recent hospital documentation
- Willingness to participate in the study and ability to read, understand and sign the informed consent document
Who cannot join
- Inability to give informed consent, including inability to read and understand English and age under 18 years
- Evidence of current skin infection or breakdown at or near the site of surgical incision
- Any immune compromised status, including AIDS
- Negative pressure wound therapy applied at time of surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples
The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.
Read the detailed description
The study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a BMI of 40 or greater. The participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. Either technique is currently standard of care. Participants who end up undergoing cesarean section will be included in the final data analysis. The participants will be followed for wound complication in the first 6 weeks post operatively. Wound complication will be defined as wound disruption or infection within 6 weeks post operatively.
Design and Project Type This study is a randomized controlled trial. At the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40 or greater. Based on this, the investigators expect the duration of the study to be 2 years. Randomization and data collection will be completed on 420 women.
Description of Intervention Two interventions will be used in this project: subcuticular suture and surgical staples. The subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. The surgical staples will be the standard staples used on the labor and delivery unit.
- Being tested
- Randomizing to Suture or Staple closure of Cesarean section
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomizing to Suture or Staple closure of Cesarean sectionProcedure or surgery
Also called suture or staples for skin closure
Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Randomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria. Receives: Procedure: Randomizing to Suture or Staple closure of Cesarean section |
| Staples | Active comparator | Women in this Arm will be assigned to Standard Surgical Staples closure of Cesarean section.
Women will have met inclusion criteria and not meet exclusion criteria and willing to consent to study. Intervention is the randomization to either Arm. Both are standard of care at this facility. Receives: Procedure: Randomizing to Suture or Staple closure of Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound complication, comparing the outcomes from the two arms
Rate of wound complication comparing the outcomes of subcuticular sutures to surgical staples for cesarean wound closure in the obese gravida during the first 6 weeks postpartum.
Measured: 2 years
Secondary outcomes (3)
Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida.
wound complication frequency
Measured: 2 years
Type and location of cesarean incisions in the obese gravida.
type and location of incisions
Measured: 2 years
Effect of medical comorbidities on wound disruption.
medical comorbidities on wound disruption
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for C.Delivery; Penetration, Pregnant Uterus, by InstrumentStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner Health
- Responsible party
- Sponsor
- Investigators
- Jordan Perlow, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549131
- Sponsor's protocol ID
- Cesarean Closure
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2015
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no individual patient data will be shared
Publications
Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
PubMed 23467047ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.
PubMed 19461456Myles TD, Gooch J, Santolaya J. Obesity as an independent risk factor for infectious morbidity in patients who undergo cesarean delivery. Obstet Gynecol. 2002 Nov;100(5 Pt 1):959-64. doi: 10.1016/s0029-7844(02)02323-2.
PubMed 12423861Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.
PubMed 20678746Conner SN, Verticchio JC, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Maternal obesity and risk of postcesarean wound complications. Am J Perinatol. 2014 Apr;31(4):299-304. doi: 10.1055/s-0033-1348402. Epub 2013 Jun 13.
PubMed 23765707Mackeen AD, Devaraj T, Baxter JK. Cesarean skin closure preferences: a survey of obstetricians. J Matern Fetal Neonatal Med. 2013 May;26(8):753-6. doi: 10.3109/14767058.2012.755509. Epub 2013 Jan 11.
PubMed 23211124Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
PubMed 12603990Pevzner L, Swank M, Krepel C, Wing DA, Chan K, Edmiston CE Jr. Effects of maternal obesity on tissue concentrations of prophylactic cefazolin during cesarean delivery. Obstet Gynecol. 2011 Apr;117(4):877-882. doi: 10.1097/AOG.0b013e31820b95e4.
PubMed 21422859McLean M, Hines R, Polinkovsky M, Stuebe A, Thorp J, Strauss R. Type of skin incision and wound complications in the obese parturient. Am J Perinatol. 2012 Apr;29(4):301-6. doi: 10.1055/s-0031-1295637. Epub 2011 Nov 21.
PubMed 22105439Thornburg LL, Linder MA, Durie DE, Walker B, Pressman EK, Glantz JC. Risk factors for wound complications in morbidly obese women undergoing primary cesarean delivery. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1544-8. doi: 10.3109/14767058.2011.653422. Epub 2012 Feb 13.
PubMed 22233403
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples
- ClinicalTrials.gov ID
- NCT02549131
- Acronym / sponsor ID
- Cesarean Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner Health
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 15 Sep 2015 (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 randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.
Detailed description
The study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a BMI of 40 or greater. The participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. Either technique is currently standard of care. Participants who end up undergoing cesarean section will be included in the final data analysis. The participants will be followed for wound complication in the first 6 weeks post operatively. Wound complication will be defined as wound disruption or infection within 6 weeks post operatively.
Design and Project Type This study is a randomized controlled trial. At the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40 or greater. Based on this, the investigators expect the duration of the study to be 2 years. Randomization and data collection will be completed on 420 women.
Description of Intervention Two interventions will be used in this project: subcuticular suture and surgical staples. The subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. The surgical staples will be the standard staples used on the labor and delivery unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: Randomizing to Suture or Staple closure of Cesarean sectionRandomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria. |
| Staples | Active comparator | Procedure: Randomizing to Suture or Staple closure of Cesarean sectionWomen in this Arm will be assigned to Standard Surgical Staples closure of Cesarean section. Women will have met inclusion criteria and not meet exclusion criteria and willing to consent to study. Intervention is the randomization to either Arm. Both are standard of care at this facility. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant woman
- Time to approach and consent the patient prior to undergoing cesarean delivery
- Able to give informed consent, include age 18 or greater and ability to read and understand English
- BMI of 40 or greater on most recent hospital documentation
- Willingness to participate in the study and ability to read, understand and sign the informed consent document
Key exclusion criteria (4 listed)
- Inability to give informed consent, including inability to read and understand English and age under 18 years
- Evidence of current skin infection or breakdown at or near the site of surgical incision
- Any immune compromised status, including AIDS
- Negative pressure wound therapy applied at time of surgery
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 |
|---|---|---|
| Randomizing to Suture or Staple closure of Cesarean sectionAlso: suture or staples for skin closureRandomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery. | Procedure or surgery | Staples, Suture |
Primary outcome
Rate of wound complication, comparing the outcomes from the two arms
Time frame: 2 years
Rate of wound complication comparing the outcomes of subcuticular sutures to surgical staples for cesarean wound closure in the obese gravida during the first 6 weeks postpartum.
3 secondary outcomes
Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida.
Time frame: 2 years
Type and location of cesarean incisions in the obese gravida.
Time frame: 2 years
Effect of medical comorbidities on wound disruption.
Time frame: 2 years
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 26 Aug 2022.
- Background: PubMed 23467047Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
- Background: PubMed 19461456ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.
- Background: PubMed 12423861Myles TD, Gooch J, Santolaya J. Obesity as an independent risk factor for infectious morbidity in patients who undergo cesarean delivery. Obstet Gynecol. 2002 Nov;100(5 Pt 1):959-64. doi: 10.1016/s0029-7844(02)02323-2.
- Background: PubMed 20678746Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.
- Background: PubMed 23765707Conner SN, Verticchio JC, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Maternal obesity and risk of postcesarean wound complications. Am J Perinatol. 2014 Apr;31(4):299-304. doi: 10.1055/s-0033-1348402. Epub 2013 Jun 13.
- Background: PubMed 23211124Mackeen AD, Devaraj T, Baxter JK. Cesarean skin closure preferences: a survey of obstetricians. J Matern Fetal Neonatal Med. 2013 May;26(8):753-6. doi: 10.3109/14767058.2012.755509. Epub 2013 Jan 11.
- Background: PubMed 12603990Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
- Background: PubMed 21422859Pevzner L, Swank M, Krepel C, Wing DA, Chan K, Edmiston CE Jr. Effects of maternal obesity on tissue concentrations of prophylactic cefazolin during cesarean delivery. Obstet Gynecol. 2011 Apr;117(4):877-882. doi: 10.1097/AOG.0b013e31820b95e4.
- Background: PubMed 22105439McLean M, Hines R, Polinkovsky M, Stuebe A, Thorp J, Strauss R. Type of skin incision and wound complications in the obese parturient. Am J Perinatol. 2012 Apr;29(4):301-6. doi: 10.1055/s-0031-1295637. Epub 2011 Nov 21.
- Background: PubMed 22233403Thornburg LL, Linder MA, Durie DE, Walker B, Pressman EK, Glantz JC. Risk factors for wound complications in morbidly obese women undergoing primary cesarean delivery. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1544-8. doi: 10.3109/14767058.2011.653422. Epub 2012 Feb 13.
- Individual participant dataSharing planned: No. no individual patient data will be shared
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.
Jordan Perlow, MD principal investigator
Pediatrix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomizing to Suture or Staple closure of Cesarean section in people with C.Delivery; Penetration, Pregnant Uterus, by Instrument and Obesity, run by Pediatrix 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 5 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: finished, as of the sponsor's last update on 26 Aug 2022. 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?
Rate of wound complication, comparing the outcomes from the two arms (time frame: 2 years). 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 NCT02549131, which also lists 10 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 26 Aug 2022.