A Randomized Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Skin Closure Time, All Resident Levels
Study Overview
Brief 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.
Detailed Description
Cesarean section is one of the most frequently performed surgical procedures worldwide. In the United States, the proportion of deliveries by cesarean has increased from approximately 21% in 1996 to 32.8% in 2010. Ultimately, the rising incidence of cesarean delivery results in increased surgical morbidity; including pain, blood loss, and surgical site infections, which leads to an increase in overall hospitalization days and healthcare costs. This volume of surgical procedures also carries the risk of blood and body fluid exposures to surgical staff. Suture needles contribute to 43.4% of all sharps injuries in surgical settings and 51.5% of sharp injuries to surgeons alone. Additionally, it was discovered that 20% of blood borne pathogen exposures on the Mayo Clinic Rochester campus in 2011 occurred in the Department of Obstetrics and Gynecology. Therefore, any quality improvement measure regarding cesarean sections has the potential to significantly impact overall surgical morbidity, bloodborne pathogen exposure, and healthcare costs at our institution. Reviews of current literature show a lack of evidence for many of the surgical steps during cesarean procedures. Thus, there is an urgent need to define evidence-based surgical techniques for each step, from incision to closure.
The optimal skin closure technique is simple, quick, cost-effective, and provides adequate tissue approximation with a good cosmetic outcome while minimizing the risk of infection, dehiscence, and pain. Ideally, needlestick injuries would also be eliminated. It is currently unknown which skin closure method is superior with regard to these outcomes.
The INSORB 20 (Incisive Surgical) is a new, single-use device for skin closure that aims to combine the speed of a staple with the cosmetic outcome of a subcuticular suture, while eliminating the need for staple removal. Additionally, it should reduce the incidence of needlestick injury. INSORB also claims to result in a "low maintenance wound" with less surgical site infection, lower inflammation, and increased patient comfort and satisfaction. However, data is limited comparing INSORB to the current standards of care (either staples or suture).
The purpose of this study is to determine if the new absorbable subcuticular staples (INSORB) improves outcomes compared to the current standard absorbable subcuticular suture for skin closure in cesarean sections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gestational age ≥ 24 weeks
- •Scheduled cesarean section for any indication
- •Pfannenstiel incision
- •Singleton gestation
Exclusion Criteria
- •Failure to consent
- •Gestational age < 24 weeks
- •Vaginal delivery
- •Intrauterine fetal death
- •Multifetal gestation
- •Suspected infection, i.e. chorioamnionitis
- •BMI > 50
Arms & Interventions
Subcuticular suture
Subcuticular suture has been used for many years to close skin incisions.
Intervention: Subcuticular suture (Device)
Subcuticular staple
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
Intervention: Subcuticular staple (Device)
Outcomes
Primary Outcomes
Skin Closure Time, All Resident Levels
Time Frame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
Measured for all resident education levels (1 to 4 years postgraduate).
Total Surgical Time, All Resident Levels
Time Frame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).
Secondary Outcomes
- Participants With Postoperative Complications, by Type(From the day of the procedure (Day 1) for 6 weeks)
- Surgeon Satisfaction (Per Procedure)(Immediately after the procedure (day 1))
- Total Number of Participants With Postoperative Complications(From the day of the procedure (Day 1) for 6 weeks)
- Postoperative Pain(From day of procedure until end of hospital stay (typical dismissal on day 4))
- Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic(From day of procedure until end of hospital stay (typical dismissal on day 4))
- Patient Satisfaction(At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment)
- Cosmetic Outcome(Measured at 6 week postoperative appointment)
Investigators
Margaret L. Dow, M.D.
M.D.
Mayo Clinic