Phase 4
N=550
Subcuticular Suture for Cesarean Skin Incision Closure
Complications; Cesarean Section · Surgical Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT02459093 ↗Enrolled (actual)
550
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc) — 23; 37; 16; 25 Participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- poliglecaprone 25 suture (Device); polyglactin 910 suture (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc) |
22; 30; 16; 20; 1; 2 | 0.05 |
Summary
A comparison of the type of suture used for cesarean skin incision approximation and the subsequent rate of wound complications has not been widely studied. Investigators seek to compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication rates (SSI, hematoma, seroma, wound separation).
Eligibility Criteria
Inclusion Criteria
- Gestational age of 37 completed weeks or greater based on their estimated due date calculated from last menstrual period or early ultrasound.
- Patients participating will be undergoing either:
- Scheduled cesarean delivery
- Non-emergent cesarean delivery
Exclusion Criteria
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal indication)
- Vertical skin incision
- Active participation in another research study
Data sourced from ClinicalTrials.gov (NCT02459093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.