Obesity, SevereNCT02466776
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
A study testing Absorbable subcuticular suture and Stainless steel staples in people with Obesity, Severe and Cesarean Section, run by MemorialCare Health System at 4 sites in United States.
Trial summary
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity, Severe, Cesarean Section
- What is being tested?
- Absorbable subcuticular suture and Stainless steel staples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 18 years old undergoing cesarean delivery (CD)
- BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
- Live gestation 23 weeks or greater
- Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
Who cannot join
- Active lupus flare
- HIV/AIDS
- Current treatment for cancer or h/o radiation to the abdomen/pelvis
- Hypersensitivity to steri-strips
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
Long Beach, California, 90806
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach
Long Beach, California, 90806
Long Beach Memorial Care Center
Long Beach, California, 90806
University of California, Irvine
Orange, California, 92868
About this study
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.
Read the detailed description
- To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).
- No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).
- At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.
- Conditions
- Obesity, Severe, Cesarean Section
- Being tested
- Absorbable subcuticular suture, Stainless steel staples
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable subcuticular sutureDevice
Also called 3-0 monocryl
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Stainless steel staplesDevice
Also called Staples
Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
| Study group | Role | What they receive |
|---|---|---|
| Stainless steel staples | Active comparator | Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD). Receives: Device: Stainless steel staples |
| Absorbable subcuticular Suture | Active comparator | Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD). Receives: Device: Absorbable subcuticular suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Measured: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Secondary outcomes (13)
Number of Participants According to Skin Incision
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery and hospitalization
Operating Surgeon Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery
Surgical Assistant Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery
Total Operative Time
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery and hospitalization
Total Blood Loss
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery
Number of Participants With Blood Transfusion
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery and hospitalization
Change in Hemoglobin (Pre-delivery and Post-delivery)
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery (pre-delivery) and post-delivery
Neonatal Birthweight
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of delivery
Number of Participants With 5 Minute Apgar Score <7
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome).
Measured: At time of delivery
Number of Participants Receiving Postpartum Prophylactic Anticoagulation
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: During hospitalization
Total Length of Hospital Stay
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Measured: At time of surgery and hospitalization
Patient Pain Score (From 1 to 10)
Patients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain).
Measured: Within 2 weeks postpartum
Patient Satisfaction With Wound Healing and Appearance
Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned).
Measured: At time of hospital discharge and at 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, SevereStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Jennifer McNulty, MD, MemorialCare Health System
- Investigators
- Jennifer McNulty, MD, Principal investigator, MemoriaCare HealthSystem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466776
- Sponsor's protocol ID
- 459-14
- Status last verified
- Dec 2023
- First submitted
- 3 Jun 2015
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02466776
- Acronym / sponsor ID
- 459-14
- Conditions
- Obesity, Severe, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 9 Jan 2024
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 the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.
Detailed description
- To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).
- No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).
- At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stainless steel staples | Active comparator | Device: Stainless steel staplesPatients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD). |
| Absorbable subcuticular Suture | Active comparator | Device: Absorbable subcuticular suturePatients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women > 18 years old undergoing cesarean delivery (CD)
- BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
- Live gestation 23 weeks or greater
- Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
Key exclusion criteria (4 listed)
- Active lupus flare
- HIV/AIDS
- Current treatment for cancer or h/o radiation to the abdomen/pelvis
- Hypersensitivity to steri-strips
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 |
|---|---|---|
| Absorbable subcuticular sutureAlso: 3-0 monocrylPatients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD). | Device | Absorbable subcuticular Suture |
| Stainless steel staplesAlso: StaplesPatients will receive stainless steel staples for skin closure at time of cesarean delivery (CD). | Device | Stainless steel staples |
Primary outcome
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Time frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
13 secondary outcomes
Number of Participants According to Skin Incision
Time frame: At time of surgery and hospitalization
Operating Surgeon Level
Time frame: At time of surgery
Surgical Assistant Level
Time frame: At time of surgery
Total Operative Time
Time frame: At time of surgery and hospitalization
Total Blood Loss
Time frame: At time of surgery
Number of Participants With Blood Transfusion
Time frame: At time of surgery and hospitalization
Change in Hemoglobin (Pre-delivery and Post-delivery)
Time frame: At time of surgery (pre-delivery) and post-delivery
Neonatal Birthweight
Time frame: At time of delivery
Number of Participants With 5 Minute Apgar Score <7
Time frame: At time of delivery
Number of Participants Receiving Postpartum Prophylactic Anticoagulation
Time frame: During hospitalization
Total Length of Hospital Stay
Time frame: At time of surgery and hospitalization
Patient Pain Score (From 1 to 10)
Time frame: Within 2 weeks postpartum
Patient Satisfaction With Wound Healing and Appearance
Time frame: At time of hospital discharge and at 2 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer McNulty, MD principal investigator
MemoriaCare HealthSystem
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable subcuticular suture and Stainless steel staples in people with Obesity, Severe and Cesarean Section, run by MemorialCare Health System at 4 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 4 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Hospital Discharge and 2 Weeks Postpartum (time frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2024.