Operative Time, Wound Heal
Conditions
Brief summary
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
Detailed description
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
Interventions
DEVICEINSORB: subcuticular stapling device
Under the skin stapling device that delivers absorbable staples
DEVICESubcuticular monocryl suture manufactured by Ethicon
Under the skin suture placed by hand
Sponsors
Cooper Companies
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
Intervention model description
Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 years of age * Women ≥ 24 weeks viable gestation * Will be undergoing cesarean delivery
Exclusion criteria
* Patient unwilling or unable to provide consent. * No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery. * Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \<200, or other * Decision not to have skin closure (e.g. secondary wound closure, mesh closure) * Current skin infection * Coagulopathy * High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery) * Incarcerated individuals * Intraamniotic infection * Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating Time | Start of surgery through end of skin closure in minutes | Total time for the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Wound Complication | Time of surgery through six weeks post partum | Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers |
| Post Operative Pain | 5-10 days | Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain. |
| Wound Cosmesis | Time of surgery through six weeks post partum | A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing. |
| Use of Resources | Time of surgery through six weeks post partum | Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures |
| Skin Closure Time in Minutes | Time of surgery through six weeks post partum | The average of minutes it takes for closure of the skin at time of surgery through weeks post partum. |
| Number of Adverse Events | Time of surgery through six weeks post partum | Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis |
Countries
United States
Participant flow
Pre-assignment details
A total of 117 participants signed the consent, 2 participants withdrew. The study terminated early due to the low accrual.
Participants by arm
| Arm | Count |
|---|---|
| Suture Wound Closure Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.
Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand | 59 |
| Absorbable Staple Wound Closure Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.
INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples | 56 |
| Total | 115 |
Baseline characteristics
| Characteristic | Suture Wound Closure | Total | Absorbable Staple Wound Closure |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 5 | 30.3 years STANDARD_DEVIATION 5.2 | 31.1 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 83 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 32 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 98 Participants | 48 Participants |
| Region of Enrollment United States | 59 participants | 115 participants | 56 participants |
| Sex: Female, Male Female | 59 Participants | 115 Participants | 56 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 / 59 | 0 / 56 |
| other Total, other adverse events | 0 / 59 | 0 / 56 |
| serious Total, serious adverse events | 0 / 59 | 0 / 56 |
Outcome results
Primary
Operating Time
Total time for the procedure
Time frame: Start of surgery through end of skin closure in minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wound Closure | Operating Time | 69.2 Minutes | Standard Deviation 23.7 |
| Absorbable Staple Wound Closure | Operating Time | 61.9 Minutes | Standard Deviation 21.2 |
Secondary
Number of Adverse Events
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Time frame: Time of surgery through six weeks post partum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture Wound Closure | Number of Adverse Events | 0 Participants |
| Absorbable Staple Wound Closure | Number of Adverse Events | 0 Participants |
Secondary
Number of Participants With Composite Wound Complication
Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
Time frame: Time of surgery through six weeks post partum
Population: Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture Wound Closure | Number of Participants With Composite Wound Complication | 0 Participants |
| Absorbable Staple Wound Closure | Number of Participants With Composite Wound Complication | 2 Participants |
Secondary
Post Operative Pain
Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain.
Time frame: 5-10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wound Closure | Post Operative Pain | .9 Units on a scale | Standard Deviation 2.2 |
| Absorbable Staple Wound Closure | Post Operative Pain | .7 Units on a scale | Standard Deviation 1.9 |
Secondary
Skin Closure Time in Minutes
The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.
Time frame: Time of surgery through six weeks post partum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wound Closure | Skin Closure Time in Minutes | 7.6 minutes | Standard Deviation 2.7 |
| Absorbable Staple Wound Closure | Skin Closure Time in Minutes | 4.1 minutes | Standard Deviation 2.67 |
Secondary
Use of Resources
Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
Time frame: Time of surgery through six weeks post partum
Population: Patients who had follow up who were sent to triage for evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture Wound Closure | Use of Resources | 0 Participants |
| Absorbable Staple Wound Closure | Use of Resources | 1 Participants |
Secondary
Wound Cosmesis
A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.
Time frame: Time of surgery through six weeks post partum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wound Closure | Wound Cosmesis | 3.9 score on a scale | Standard Deviation 1 |
| Absorbable Staple Wound Closure | Wound Cosmesis | 3.2 score on a scale | Standard Deviation 1.2 |