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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staples | Active Comparator | Use of staples for skin closure at cesarean section |
|
| Prolene non-absorbable sutures | Active Comparator | Use of Prolene non-absorbable sutures for skin closure at cesarean section |
|
| Absorbable sutures | Active Comparator | Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staples | Procedure | Staples for closure of cesarean section skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Post-operative day 3 or 4. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post-operative week 6 |
| Count of Participants With Wound Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natali Aziz, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Childrens Hospital | Palo Alto | California | 94304 | United States |
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Recruitment into the first two arms (Staples and Prolene non-absorbable sutures) occurred through May 2013. The study protocol was modified in July 2014 and the third arm of the study, absorbable sutures, was added, however, no recruitment occurred after this modification.
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| ID | Title | Description |
|---|---|---|
| FG000 | Staples | Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision |
| FG001 | Prolene Non-absorbable Sutures | Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision |
| FG002 | Absorbable Sutures | Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl. Absorbable Sutures: Absorbable sutures for closure of cesarean skin incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No enrollment occurred after adding the "absorbable sutures" study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Staples | Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision |
| BG001 | Prolene Non-absorbable Sutures | Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative day 3 or 4. |
|
Up to 6 weeks after cesarean delivery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Staples | Use of staples for skin closure at cesarean section Staples: Staples for closure of cesarean section skin incision |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Operations Manager | Stanford University | 6507255720 | agirsen@stanford.edu |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| C095495 | glycolide E-caprolactone copolymer |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Prolene non-absorbable sutures | Procedure | Prolene non-absorbable sutures for closure of cesarean skin incision |
|
|
| Absorbable Sutures | Procedure | Absorbable sutures for closure of cesarean skin incision |
|
|
Wound complications include conditions like infection, seroma/hematoma and dehiscence
| 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) | 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) | Post-operative week 6 |
| Time From Skin Incision to the Skin Closure | Measured in minutes | Day of cesarean delivery (up to 8 hours) |
| Time Needed for the Suture Removal | Measured in seconds | 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) | 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) | 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) | 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) | Post-operative week 6 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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). | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative week 6 |
|
|
|
| Secondary | Count of Participants With Wound Complications | Wound complications include conditions like infection, seroma/hematoma and dehiscence | Only patients with available data were included in the analysis. | Posted | Count of Participants | Participants | Post-operative week 6 |
|
|
|
| Secondary | Level of Patient Satisfaction to the Wound Appearance | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative day 3 or 4 |
|
|
|
| Secondary | 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) | There were no patients that had data available for analysis for "staples" and "prolene non-absorbable sutures" study arms. | Posted | Post-operative week 6 |
|
|
| Secondary | Time From Skin Incision to the Skin Closure | Measured in minutes | Posted | Median | Inter-Quartile Range | minutes | Day of cesarean delivery (up to 8 hours) |
|
|
|
| Secondary | Time Needed for the Suture Removal | Measured in seconds | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | seconds | Post-operative day 3 or 4 |
|
|
|
| Secondary | 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) | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative week 6 |
|
|
|
| Secondary | 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) | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative day 1 |
|
|
|
| Secondary | 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) | Only patients with available data were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Post-operative day 3 or 4 |
|
|
|
| Secondary | 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) | No patients had data available for the analysis. | Posted | Post-operative week 6 |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Prolene Non-absorbable Sutures | Use of Prolene non-absorbable sutures for skin closure at cesarean section Prolene non-absorbable sutures: Prolene non-absorbable sutures for closure of cesarean skin incision | 0 | 8 | 0 | 8 |
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