Cesarean Section, Complication, Wound
Conditions
Keywords
Complications, Wound, Hematoma, Surgical Incision
Brief summary
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
Detailed description
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
Interventions
DEVICEDermabond Prineo
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
OTHERSuture
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age 18 years or older * All women scheduled for primary or repeat cesarean deliveries * All women undergoing intrapartum or antepartum cesarean delivery * Pfannenstiel skin incision * Birth of a live infant at time of cesarean delivery
Exclusion criteria
* Vertical skin incision * Cesarean hysterectomy * Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc) * Intrapartum stillbirth * Planned postpartum follow up at another facility * Contraindications to routine postpartum pain medications * Adhesive or tape allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Scar Satisfaction Scale Score | Assessed at 6-weeks postpartum | The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) | Assessed during delivery hospitalization and at 6-week follow-up | A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence. |
| Skin Closure Time | Intraoperative | The skin closure time will be assessed. |
| Operative Time | Intraoperative | The total operative time will be assessed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRussell Miller, MD
Columbia University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 73 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 78 |
| other Total, other adverse events | 9 / 73 | 8 / 78 |
| serious Total, serious adverse events | 5 / 73 | 11 / 78 |
Outcome results
None listed