Wound Complication, Complications; Cesarean Section
Conditions
Brief summary
The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.
Interventions
DEVICETissue Adhesive
DEVICESterile strips
Sponsors
University of Chicago
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing Pfannenstiel Cesarean delivery
Exclusion criteria
* Inability to provide informed consent in English * Planned use of staples for skin closure * Unavailability of research personnel to accomplish consent and randomization at the time of cesarean
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Complication | 6-8 weeks from cesarean delivery | Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | At time of delivery | The investigators will review operative records to assess operative time |
| Number of Participants With Readmission for Wound Complication | Within 8 weeks from cesarean delivery | — |
| Satisfaction With Cesarean Scar | 6-8 weeks from cesarean delivery | The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool. |
| Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | Within 8 weeks of delivery | The investigators will review medical records to assess for ambulatory visits for wound complaints |
| Number of Participants Requiring Antibiotic Treatment for Wound Complication | Within 8 weeks of delivery | The investigators will review medical records to assess for antibiotic prescriptions for wound complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tissue Adhesive Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive | 252 |
| Steri-Strips Sterile strips will be placed over subcuticular suture closure.
Sterile strips | 252 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 11 |
Baseline characteristics
| Characteristic | Steri-Strips | Tissue Adhesive | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years | 34 years | 34 years |
| Blood loss | 745.0 mL | 700.0 mL | 700.0 mL |
| Body mass index at delivery | 33.5 kg/m^2 | 32.9 kg/m^2 | 33.3 kg/m^2 |
| Cesarean delivery while in labor | 56 Participants | 64 Participants | 120 Participants |
| Chorioamnionitis | 10 Participants | 11 Participants | 21 Participants |
| Diabetes mellitus | 44 Participants | 30 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 30 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 204 Participants | 191 Participants | 395 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 31 Participants | 51 Participants |
| Hypertensive disorders | 57 Participants | 54 Participants | 111 Participants |
| Immunocompromised | 3 Participants | 4 Participants | 7 Participants |
| Nulliparity | 25 Participants | 25 Participants | 50 Participants |
| Prior cesarean delivery | 140 Participants | 144 Participants | 284 Participants |
| Race/Ethnicity, Customized Asian | 31 Participants | 29 Participants | 60 Participants |
| Race/Ethnicity, Customized Black or African American | 65 Participants | 74 Participants | 139 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 31 Participants | 51 Participants |
| Race/Ethnicity, Customized White | 139 Participants | 121 Participants | 260 Participants |
| Sex: Female, Male Female | 252 Participants | 252 Participants | 504 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco use | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 252 |
| other Total, other adverse events | 0 / 252 | 0 / 252 |
| serious Total, serious adverse events | 0 / 252 | 0 / 252 |
Outcome results
Primary
Number of Participants With Wound Complication
Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
Time frame: 6-8 weeks from cesarean delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tissue Adhesive | Number of Participants With Wound Complication | 18 Participants |
| Sterile Strips | Number of Participants With Wound Complication | 19 Participants |
Secondary
Number of Participants Requiring Antibiotic Treatment for Wound Complication
The investigators will review medical records to assess for antibiotic prescriptions for wound complications
Time frame: Within 8 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tissue Adhesive | Number of Participants Requiring Antibiotic Treatment for Wound Complication | 7 Participants |
| Sterile Strips | Number of Participants Requiring Antibiotic Treatment for Wound Complication | 12 Participants |
Secondary
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
The investigators will review medical records to assess for ambulatory visits for wound complaints
Time frame: Within 8 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tissue Adhesive | Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | 16 Participants |
| Sterile Strips | Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | 18 Participants |
Secondary
Number of Participants With Readmission for Wound Complication
Time frame: Within 8 weeks from cesarean delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tissue Adhesive | Number of Participants With Readmission for Wound Complication | 1 Participants |
| Sterile Strips | Number of Participants With Readmission for Wound Complication | 1 Participants |
Secondary
Operative Time
The investigators will review operative records to assess operative time
Time frame: At time of delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tissue Adhesive | Operative Time | 58.5 min |
| Sterile Strips | Operative Time | 60 min |
Secondary
Satisfaction With Cesarean Scar
The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool.
Time frame: 6-8 weeks from cesarean delivery
Population: Completion of the modified Patient Scar Assessment Scale was accomplished in 203/252 (80.6%) of women in the tissue adhesive group and 203/252 (80.6%) of women in the sterile strips group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tissue Adhesive | Satisfaction With Cesarean Scar | 1 score on a scale |
| Sterile Strips | Satisfaction With Cesarean Scar | 2 score on a scale |