N/A
Completed N=220
A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Surgical Wound
Source: ClinicalTrials.gov NCT01753518 ↗
Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Total Surgical Time, All Resident Levels — 58.0; 54.0 minutes — p=0.053
Summary
Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin.
There is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Surgical Time, All Resident Levels |
58.0; 54.0 | 0.053 |
| PRIMARY Skin Closure Time, All Resident Levels |
8.5; 2.6 | <0.001 sig |
| SECONDARY Total Number of Participants With Postoperative Complications |
7; 6 | 0.73 |
| SECONDARY Participants With Postoperative Complications, by Type |
0; 3; 4; 1; 4; 1 | 0.25 |
| SECONDARY Postoperative Pain |
12000; 12000; 5400; 4800; 45; 45 | 0.48 |
| SECONDARY Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic |
5; 6; 6; 9; 16; 22 | — |
| SECONDARY Patient Satisfaction |
3; 6; 55; 63; 11; 6 | 0.51 |
| SECONDARY Surgeon Satisfaction (Per Procedure) |
6; 7; 85; 89; 14; 3 | 0.85 |
| SECONDARY Cosmetic Outcome |
2.2; 1.8; 2.2; 1.9; 5.3; 3.9 | 0.35 |
Eligibility Criteria
Inclusion criteria
- Gestational age ≥ 24 weeks
- Scheduled cesarean section for any indication
- Pfannenstiel incision
- Singleton gestation
Exclusion criteria
- Failure to consent
- Gestational age 50
Data sourced from ClinicalTrials.gov (NCT01753518). 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. Informational only — not medical advice.