Cesarean Section, Pregnancy
Conditions
Keywords
cesarean section, insorb staples, absorbable staples, transverse skin incision
Brief summary
The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar.
Detailed description
The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study during the routine consent process which includes consent for cesarean section that occurs with each patient. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. The size of the suture (3-0 vs. 4-0) and type of needle used to sew is at the discretion of the surgeon. The indications for and performance of the cesarean section will remain standard care by the Obstetrical team and the patient's participation in this study will have no impact whatsoever on the obstetrical course of the patient. The only additional procedure that will be asked of the obstetrical team performing the cesarean section is to measure and close the subcutaneous tissue if the depth from the skin edge to the transversalis fascia is greater than 2cm as this has been shown to decrease subsequent seroma formation and wound disruption. The dressing will be standardized as follows: a folded abdominal (ABD) pad will be placed in a sterile fashion directly over the incision and foam tape will be applied to provide a pressure dressing. The dressing will be removed on post-operative day #2. The patient's postoperative course will remain unchanged and her discharge will be at the discretion of her obstetrical providers. On post-operative day #3, a picture of the incision will be taken with the patient's identifying number adjacent to the picture and the patient will be asked to complete a brief survey asking about post-operative pain and scars (see included PSAS survey). The patients will follow-up with her Obstetrician for her normal post-partum visit where another picture of the incision will be taken. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar. At this point, the patient's participation in the study will end.
Interventions
COMBINATION_PRODUCTInsorb absorbable staples
Placement of Insorb absorbable staples at cesarean section
COMBINATION_PRODUCTAbsorbable sutures
placement of absorbable sutures at cesarean section
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* cesarean section via transverse skin incision informed consent
Exclusion criteria
* vertical skin incision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Scale | 3 months | Visual Analog Score 0-10, with 0 being painless and 10 being the most severe |
| Patient Scar Assessment Scale (PSAS) | 6 weeks | assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin. |
| Closure Time | up to 20 minutes post intervention | Number of minutes taken to close post cesarean section |
Countries
United States
Participant flow
Recruitment details
187 were consented, and 88 were randomized to intervention versus placebo.
Participants by arm
| Arm | Count |
|---|---|
| Sutures Absorbable sutures: placement of absorbable sutures at cesarean section | 44 |
| Insorb Staples Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Sutures | Insorb Staples | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 44 Participants | 88 Participants |
| Region of Enrollment United States | 44 participants | 44 participants | 88 participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 88 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 | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Closure Time
Number of minutes taken to close post cesarean section
Time frame: up to 20 minutes post intervention
Population: Data was not collected for all participants enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sutures | Closure Time | 4.161 minutes |
| Insorb Staples | Closure Time | 9.79 minutes |
Primary
Patient Pain Scale
Visual Analog Score 0-10, with 0 being painless and 10 being the most severe
Time frame: 3 months
Population: Data was not collected for all participants enrolled due to failure to follow-up post intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sutures | Patient Pain Scale | 2.375 units on a scale |
| Insorb Staples | Patient Pain Scale | 3.053 units on a scale |
Primary
Patient Scar Assessment Scale (PSAS)
assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.
Time frame: 6 weeks
Population: Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sutures | Patient Scar Assessment Scale (PSAS) | 20 units on a scale |
| Insorb Staples | Patient Scar Assessment Scale (PSAS) | 13 units on a scale |