N/A
N=238
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Obesity, Severe · Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT02466776 ↗Enrolled (actual)
238
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum — 8; 5; 15; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Absorbable subcuticular suture (Device); Stainless steel staples (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MemorialCare Health System
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum |
8; 5; 15; 16; 23; 21 | — |
| SECONDARY Number of Participants According to Skin Incision |
114; 118; 5; 1 | — |
| SECONDARY Operating Surgeon Level |
67; 66; 52; 53 | — |
| SECONDARY Surgical Assistant Level |
101; 97; 18; 22 | — |
| SECONDARY Total Operative Time |
43.4; 55.8 | — |
| SECONDARY Total Blood Loss |
773; 837 | — |
| SECONDARY Number of Participants With Blood Transfusion |
4; 8 | — |
| SECONDARY Change in Hemoglobin (Pre-delivery and Post-delivery) |
1.68; 1.93 | — |
| SECONDARY Neonatal Birthweight |
3406; 3426 | — |
| SECONDARY Number of Participants With 5 Minute Apgar Score <7 |
2; 1 | — |
| SECONDARY Number of Participants Receiving Postpartum Prophylactic Anticoagulation |
66; 74 | — |
| SECONDARY Total Length of Hospital Stay |
4.9; 4.9 | — |
| SECONDARY Patient Pain Score (From 1 to 10) |
2; 2 | — |
| SECONDARY Patient Satisfaction With Wound Healing and Appearance |
10; 10; 1; 1 | — |
Summary
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.
Eligibility Criteria
Inclusion Criteria
- Women > 18 years old undergoing cesarean delivery (CD)
- BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
- Live gestation 23 weeks or greater
- Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
Exclusion Criteria
- Active lupus flare
- HIV/AIDS
- Current treatment for cancer or h/o radiation to the abdomen/pelvis
- Hypersensitivity to steri-strips
Data sourced from ClinicalTrials.gov (NCT02466776). 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.