Cesarean Section, Seroma, Surgical Site Infection, Wound Dehiscence
Conditions
Keywords
Cesarean Section, Cesarean Delivery, C-Section, Steri-Strips, Skin Closure, Wound Closure, Surgical Site Infection, Wound Dehiscence, Seroma, Postoperative Wound Complications, Obstetric Surgery, Incision Management, Surgical Wound Healing, Maternal Morbidity, Randomized Controlled Trial
Brief summary
This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method. Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions. Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups. The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.
Interventions
DEVICESteri-Strip™ Skin Closures
Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.
PROCEDUREStandard Cesarean Wound Closure
Standard skin closure performed following cesarean delivery according to institutional practice.
Sponsors
Riverside University Health System Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Neither participants nor treating clinicians will be blinded to treatment allocation because Steri-Strip application is readily visible following surgery.
Intervention model description
Participants will be assigned using 1:1 block randomization to one of two study arms. The intervention arm will receive Steri-Strip application following standard cesarean wound closure, while the control arm will receive standard wound closure alone. Participants will remain in their assigned group throughout the study, and outcomes will be assessed within 30 days postpartum.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients age 18 years or older * Pregnant patients undergoing cesarean delivery at Riverside University Health System Medical Center (RUHS) * Able and willing to provide informed consent
Exclusion criteria
* Known allergy or hypersensitivity to Steri-Strip™ materials or adhesives * Inability or unwillingness to provide informed consent * Anticipated inability to complete the 30-day postpartum follow-up evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cesarean Section Wound Complications | Within 30 days postpartum | Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | From cesarean delivery until hospital discharge (up to 7 days) | Duration of hospitalization measured from cesarean delivery until discharge. |
| Readmission Related to Wound Complications | Within 30 days postpartum | Hospital readmission attributable to wound infection, seroma, or wound separation/dehiscence following cesarean delivery. |
| Cost of Wound Management | From cesarean delivery through 30 days postpartum | Comparison of direct healthcare costs associated with wound closure materials and management of postoperative wound complications between study groups. |
Countries
United States
Contacts
CONTACTMatthew Perera, DO, MS
Outcome results
None listed