Pregnancy, Cesarean Section
Conditions
Brief 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. 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.
Interventions
PROCEDUREStaples
Staples for closure of cesarean section skin incision
PROCEDUREProlene non-absorbable sutures
Prolene non-absorbable sutures for closure of cesarean skin incision
PROCEDUREAbsorbable Sutures
Absorbable sutures for closure of cesarean skin incision
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Pain on a Scale During the Post-operative Hospitalization Period | Post-operative day 3 or 4. | Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Wound Complications | Post-operative week 6 | Wound complications include conditions like infection, seroma/hematoma and dehiscence |
| Level of Patient Satisfaction to the Wound Appearance | Post-operative day 3 or 4 | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) |
| Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum | Post-operative week 6 | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) |
| Level of Pain on a Scale at 6 Weeks Postpartum | Post-operative week 6 | Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain). |
| Time Needed for the Suture Removal | Post-operative day 3 or 4 | Measured in seconds |
| Level of Patient's Satisfaction to the Cosmesis of the Wound | Post-operative week 6 | Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis) |
| Level of Patient's Overall Patient Satisfaction to the Type of Closure | Post-operative day 1 | Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied) |
| Time From Skin Incision to the Skin Closure | Day of cesarean delivery (up to 8 hours) | Measured in minutes |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Staples Use of staples for skin closure at cesarean section
Staples: Staples for closure of cesarean section skin incision | 7 |
| 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 | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Staples | Prolene Non-absorbable Sutures | Total |
|---|---|---|---|
| Age, Continuous | 33.0 years | 33.5 years | 33.3 years |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
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)
Time frame: Post-operative day 3 or 4.
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Level of Pain on a Scale During the Post-operative Hospitalization Period | 2.0 units on a scale |
| Prolene Non-absorbable Sutures | Level of Pain on a Scale During the Post-operative Hospitalization Period | 2.0 units on a scale |
p-value: 0.6t-test, 2 sided
Secondary
Count of Participants With Wound Complications
Wound complications include conditions like infection, seroma/hematoma and dehiscence
Time frame: Post-operative week 6
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staples | Count of Participants With Wound Complications | 0 Participants |
| Prolene Non-absorbable Sutures | Count of Participants With Wound Complications | 0 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).
Time frame: Post-operative week 6
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Level of Pain on a Scale at 6 Weeks Postpartum | 3 units on a scale |
| Prolene Non-absorbable Sutures | Level of Pain on a Scale at 6 Weeks Postpartum | 1 units on a scale |
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)
Time frame: Post-operative day 3 or 4
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prolene Non-absorbable Sutures | Level of Patient Satisfaction to the Wound Appearance | 9 units on a scale |
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)
Time frame: Post-operative week 6
Population: There were no patients that had data available for analysis for staples and prolene non-absorbable sutures study arms.
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)
Time frame: Post-operative week 6
Population: No patients had data available for the analysis.
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)
Time frame: Post-operative day 1
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Level of Patient's Overall Patient Satisfaction to the Type of Closure | 8.0 units on a scale |
| Prolene Non-absorbable Sutures | Level of Patient's Overall Patient Satisfaction to the Type of Closure | 7.5 units on a scale |
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)
Time frame: Post-operative day 3 or 4
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prolene Non-absorbable Sutures | Level of Patient's Overall Patient Satisfaction to the Type of Closure | 8.7 units on a scale |
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)
Time frame: Post-operative week 6
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Level of Patient's Satisfaction to the Cosmesis of the Wound | 9.0 units on a scale |
| Prolene Non-absorbable Sutures | Level of Patient's Satisfaction to the Cosmesis of the Wound | 5.0 units on a scale |
Secondary
Time From Skin Incision to the Skin Closure
Measured in minutes
Time frame: Day of cesarean delivery (up to 8 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Time From Skin Incision to the Skin Closure | 55.0 minutes |
| Prolene Non-absorbable Sutures | Time From Skin Incision to the Skin Closure | 56.5 minutes |
Secondary
Time Needed for the Suture Removal
Measured in seconds
Time frame: Post-operative day 3 or 4
Population: Only patients with available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Staples | Time Needed for the Suture Removal | 79.0 seconds |
| Prolene Non-absorbable Sutures | Time Needed for the Suture Removal | 1.5 seconds |