ObesityNCT01820221
Sutures vs. Staples Skin Closure After C-section in Obese Patients
A study testing Suture vs. staples closure method after c-section in obese women. in people with Obesity and Pregnancy, run by University of Arkansas at 1 site in United States.
Trial summary
This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Suture vs. staples closure method after c-section in obese women.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 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
- 18 years or older
- BMI ≥ 30kg/m2 on admission to labor and delivery
- Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
- Singleton pregnancies
- Gestational age ≥ 24weeks
- Cesarean delivery performed under regional anesthesia
Who cannot join
- Refusal to participate
- BMI < 30kg/m2
- < 24 weeks gestation
- Intrauterine fetal demise
- Chronic pain syndrome requiring chronic narcotic use
- Emergent clinical situations which preclude obtaining informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients
This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.
- Being tested
- Suture vs. staples closure method after c-section in obese women.
- Keywords
- cesarean delivery, wound complications, skin closure methods
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture vs. staples closure method after c-section in obese women.Procedure or surgery
Random card draw to either suture skin closure or staple skin closure arm of study.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Skin closure with suture | Active comparator | Subjects in this group will be randomized to suture for skin closure with computer generated random card draw. Receives: Procedure: Suture vs. staples closure method after c-section in obese women. |
| Arm 2: Skin closure with staples | Active comparator | Subjects randomized to skin closure with staples with computer generated random card draw. Receives: Procedure: Suture vs. staples closure method after c-section in obese women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complication rates
Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI).
- Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given.
- Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes:
- Seroma: collection of serous fluid in the wound without evidence of infection
- Hematoma: Demonstrable blood clot between the rectus fascia and the skin
- Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.
Measured: 6 weeks postpartum
Secondary outcomes (1)
Post-operative pain
To allow for adequate monitoring and assessment of postoperative pain, standardized postoperative pain analgesia protocol at our institution will be followed. This comprises of non-steroidal anti- inflammatory drugs and Narcotics as needed. Patients will be asked to complete a visual analog pain scale ranging from 0-10 on postoperative day 2. Information on use of pain medication during hospitalization and frequency will also be collected from the medical record.
Measured: 72 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Low enrollment and Pi had no time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary L Racher, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820221
- Sponsor's protocol ID
- 138350
- Status last verified
- Feb 2017
- First submitted
- 19 Mar 2013
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients
- ClinicalTrials.gov ID
- NCT01820221
- Acronym / sponsor ID
- 138350
- Keywords
- cesarean delivery, wound complications, skin closure methods
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment and Pi had no time.
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Mar 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.
This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Skin closure with suture | Active comparator | Procedure: Suture vs. staples closure method after c-section in obese women.Subjects in this group will be randomized to suture for skin closure with computer generated random card draw. |
| Arm 2: Skin closure with staples | Active comparator | Procedure: Suture vs. staples closure method after c-section in obese women.Subjects randomized to skin closure with staples with computer generated random card draw. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years or older
- BMI ≥ 30kg/m2 on admission to labor and delivery
- Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
- Singleton pregnancies
- Gestational age ≥ 24weeks
Key exclusion criteria (6 listed)
- Refusal to participate
- BMI < 30kg/m2
- < 24 weeks gestation
- Intrauterine fetal demise
- Chronic pain syndrome requiring chronic narcotic use
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 |
|---|---|---|
| Suture vs. staples closure method after c-section in obese women.Random card draw to either suture skin closure or staple skin closure arm of study. | Procedure or surgery | Arm 1: Skin closure with suture, Arm 2: Skin closure with staples |
Primary outcome
Wound complication rates
Time frame: 6 weeks postpartum
Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI). 1. Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given. 2. Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes: * Seroma: collection of serous fluid in the wound without evidence of infection * Hematoma: Demonstrable blood clot between the rectus fascia and the skin * Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.
1 secondary outcome
Post-operative pain
Time frame: 72 hours postpartum
Results and safety
The study was stopped early (reason given: Low enrollment and Pi had no time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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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.
Mary L Racher, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture vs. staples closure method after c-section in obese women. in people with Obesity and Pregnancy, run by University of Arkansas 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Feb 2017. 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 was stopped early (reason given: Low enrollment and Pi had no time.). 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?
Wound complication rates (time frame: 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 3 Feb 2017.