Cesarean Section
Conditions
Keywords
metallic staples, absorbable staples, Cesarean Delivery
Brief summary
The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.
Detailed description
The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered superior in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care. After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.
Interventions
Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
DEVICEInsorb
Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Obstetric service patients (receiving prenatal care from the Faculty Medical Center) * Women greater than 18 years old * Singleton gestation * Cesarean Section performed by Pfannenstiel skin incision
Exclusion criteria
* History of drug or alcohol abuse * Contraindication to post operative NSAID's or Narcotics * Emergent Cesarean Deliveries * Less then 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain | 1 Year | Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. |
| Post Operative Pain (3 Days Post-op) | 1 Year | Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | This will be assessed 3 day after the patient's C-section before they are discharged from the hospital | Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples | 50 |
| Case Group This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control Group | Case Group | Total |
|---|---|---|---|
| Age, Continuous | 28.32 years STANDARD_DEVIATION 5.63 | 27.38 years STANDARD_DEVIATION 6.15 | 27.85 years STANDARD_DEVIATION 5.89 |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black/African American | 22 participants | 23 participants | 45 participants |
| Race/Ethnicity, Customized Pacific Islander | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White/Caucasian | 24 participants | 26 participants | 50 participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 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 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Post Operative Pain
Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Time frame: 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Post Operative Pain | 2.56 units on a scale | Standard Error 1.47 |
| Case Group | Post Operative Pain | 2.90 units on a scale | Standard Error 1.54 |
Primary
Post Operative Pain (3 Days Post-op)
Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Time frame: 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Post Operative Pain (3 Days Post-op) | 2.66 units on a scale | Standard Deviation 1.47 |
| Case Group | Post Operative Pain (3 Days Post-op) | 3.52 units on a scale | Standard Deviation 5.8 |
Secondary
Patient Satisfaction
Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.
Time frame: This will be assessed 3 day after the patient's C-section before they are discharged from the hospital
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Patient Satisfaction | 16 participants |
| Case Group | Patient Satisfaction | 14 participants |
Secondary
Patient Satisfaction
Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.
Time frame: Patient satisfaction will be assessed 6 weeks later at their post-op visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Patient Satisfaction | 20 participants |
| Case Group | Patient Satisfaction | 21 participants |