N/A
N=15
Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Pregnancy · Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT01509950 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Level of Pain on a Scale During the Post-operative Hospitalization Period — 2.0; 2.0 units on a scale — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Staples (Procedure); Prolene non-absorbable sutures (Procedure); Absorbable Sutures (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Pain on a Scale During the Post-operative Hospitalization Period |
2.0; 2.0 | 0.60 |
| SECONDARY Level of Pain on a Scale at 6 Weeks Postpartum |
3; 1 | — |
| SECONDARY Count of Participants With Wound Complications |
0; 0 | — |
| SECONDARY Level of Patient Satisfaction to the Wound Appearance |
9 | — |
| SECONDARY Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum |
— | — |
| SECONDARY Time From Skin Incision to the Skin Closure |
55.0; 56.5 | — |
| SECONDARY Time Needed for the Suture Removal |
79.0; 1.5 | — |
| SECONDARY Level of Patient's Satisfaction to the Cosmesis of the Wound |
9.0; 5.0 | — |
| SECONDARY Level of Patient's Overall Patient Satisfaction to the Type of Closure |
— | — |
| SECONDARY Level of Patient's Overall Patient Satisfaction to the Type of Closure |
— | — |
| SECONDARY Level of Patient's Overall Patient Satisfaction to the Type of Closure |
— | — |
Summary
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
Eligibility Criteria
Inclusion Criteria
- Pregnant women undergoing primary or repeat cesarean section
- Maternal age greater than or equal to 18 years of age
- Gestational age greater than or equal to 34 weeks
- Elective and non-elective cesarean section
Exclusion Criteria
- Type 1 or Type 2 diabetes
- BMI greater than 35
- Pre-operative diagnosis of chorioamnionitis
- History of drug or alcohol abuse
- Contraindication to NSAIDs
- Chronic pain diagnosis
- Narcotic use prior to pregnancy
- Maternal age less than 18 years of age
- General anesthesia
- Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)
- Vertical skin incision
Data sourced from ClinicalTrials.gov (NCT01509950). 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.