PregnancyNCT01509950
Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
A study testing Staples, Prolene non-absorbable sutures and Absorbable Sutures in people with Pregnancy and Cesarean Section, run by Stanford University at 1 site in United States.
Trial summary
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy, Cesarean Section
- What is being tested?
- Staples, Prolene non-absorbable sutures and Absorbable Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 4 May 2013
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing primary or repeat cesarean section
- Maternal age greater than or equal to 18 years of age
- Gestational age greater than or equal to 34 weeks
- Elective and non-elective cesarean section
Who cannot join
- Type 1 or Type 2 diabetes
- BMI greater than 35
- Pre-operative diagnosis of chorioamnionitis
- History of drug or alcohol abuse
- Contraindication to NSAIDs
- Chronic pain diagnosis
Show all 11Show fewer
- Narcotic use prior to pregnancy
- Maternal age less than 18 years of age
- General anesthesia
- Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)
- Vertical skin incision
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Childrens Hospital
Palo Alto, California, 94304
About this study
Official title: Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
Read the detailed description
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.
When a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.
Pain level will be assessed on the first and third or fourth day after surgery and again at six weeks.
- Conditions
- Pregnancy, Cesarean Section
- Being tested
- Staples, Prolene non-absorbable sutures, Absorbable Sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaplesProcedure or surgery
Also called Reflex one skin stapler 35 wide. Manufactured by Conmed
Staples for closure of cesarean section skin incision
Prolene non-absorbable suturesProcedure or surgery
Also called Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon
Prolene non-absorbable sutures for closure of cesarean skin incision
Absorbable SuturesProcedure or surgery
Also called Monocryl or Vicryl. Manufactured by Ethicon
Absorbable sutures for closure of cesarean skin incision
| Study group | Role | What they receive |
|---|---|---|
| Staples | Active comparator | Use of staples for skin closure at cesarean section Receives: Procedure: Staples |
| Prolene non-absorbable sutures | Active comparator | Use of Prolene non-absorbable sutures for skin closure at cesarean section Receives: Procedure: Prolene non-absorbable sutures |
| Absorbable sutures | Active comparator | Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl. Receives: Procedure: Absorbable Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain on a Scale During the Post-operative Hospitalization Period
Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)
Measured: Post-operative day 3 or 4.
Secondary outcomes (10)
Level of Pain on a Scale at 6 Weeks Postpartum
Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).
Measured: Post-operative week 6
Count of Participants With Wound Complications
Wound complications include conditions like infection, seroma/hematoma and dehiscence
Measured: Post-operative week 6
Level of Patient Satisfaction to the Wound Appearance
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Measured: Post-operative day 3 or 4
Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Measured: Post-operative week 6
Time From Skin Incision to the Skin Closure
Measured in minutes
Measured: Day of cesarean delivery (up to 8 hours)
Time Needed for the Suture Removal
Measured in seconds
Measured: Post-operative day 3 or 4
Level of Patient's Satisfaction to the Cosmesis of the Wound
Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)
Measured: Post-operative week 6
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Measured: Post-operative day 1
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Measured: Post-operative day 3 or 4
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Measured: Post-operative week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion4 May 2013
- Study completion4 May 2013
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 PregnancyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natali Aziz, Stanford University
- Investigators
- Natali Aziz, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509950
- Sponsor's protocol ID
- 22389
- Status last verified
- Nov 2018
- First submitted
- 5 Jan 2012
- Last updated
- 4 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
- ClinicalTrials.gov ID
- NCT01509950
- Acronym / sponsor ID
- 22389
- Conditions
- Pregnancy, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 4 May 2013 (actual)
- Study completion
- 4 May 2013 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
Detailed description
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.
When a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.
Pain level will be assessed on the first and third or fourth day after surgery and again at six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staples | Active comparator | Procedure: StaplesUse of staples for skin closure at cesarean section |
| Prolene non-absorbable sutures | Active comparator | Procedure: Prolene non-absorbable suturesUse of Prolene non-absorbable sutures for skin closure at cesarean section |
| Absorbable sutures | Active comparator | Procedure: Absorbable SuturesUse of absorbable sutures for skin closure at cesarean section; monocryl or vicryl. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women undergoing primary or repeat cesarean section
- Maternal age greater than or equal to 18 years of age
- Gestational age greater than or equal to 34 weeks
- Elective and non-elective cesarean section
Key exclusion criteria (11 listed)
- Type 1 or Type 2 diabetes
- BMI greater than 35
- Pre-operative diagnosis of chorioamnionitis
- History of drug or alcohol abuse
- Contraindication to NSAIDs
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 |
|---|---|---|
| StaplesAlso: Reflex one skin stapler 35 wide. Manufactured by ConmedStaples for closure of cesarean section skin incision | Procedure or surgery | Staples |
| Prolene non-absorbable suturesAlso: Prolene 2-0 18 inch on FS needle. Manufactured by EthiconProlene non-absorbable sutures for closure of cesarean skin incision | Procedure or surgery | Prolene non-absorbable sutures |
| Absorbable SuturesAlso: Monocryl or Vicryl. Manufactured by EthiconAbsorbable sutures for closure of cesarean skin incision | Procedure or surgery | Absorbable sutures |
Primary outcome
Level of Pain on a Scale During the Post-operative Hospitalization Period
Time frame: Post-operative day 3 or 4.
Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)
10 secondary outcomes
Level of Pain on a Scale at 6 Weeks Postpartum
Time frame: Post-operative week 6
Count of Participants With Wound Complications
Time frame: Post-operative week 6
Level of Patient Satisfaction to the Wound Appearance
Time frame: Post-operative day 3 or 4
Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum
Time frame: Post-operative week 6
Time From Skin Incision to the Skin Closure
Time frame: Day of cesarean delivery (up to 8 hours)
Time Needed for the Suture Removal
Time frame: Post-operative day 3 or 4
Level of Patient's Satisfaction to the Cosmesis of the Wound
Time frame: Post-operative week 6
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Time frame: Post-operative day 1
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Time frame: Post-operative day 3 or 4
Level of Patient's Overall Patient Satisfaction to the Type of Closure
Time frame: Post-operative week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Natali Aziz, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staples, Prolene non-absorbable sutures and Absorbable Sutures in people with Pregnancy and Cesarean Section, run by Stanford University 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 4 inclusion and 11 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 4 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2019). 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?
Level of Pain on a Scale During the Post-operative Hospitalization Period (time frame: Post-operative day 3 or 4.). 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 4 Mar 2019.