Clinical trial NCT01753518: A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Official title: A Randomized Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: Subcuticular suture
Subcuticular staple
Skin closure
Incision closure
Wound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 24 weeks
* Vaginal delivery
* Intrauterine fetal death
* Multifetal gestation
* Suspected infection, i.e. chorioamnionitis
* BMI \> 50

Primary outcomes:
measure: Total Surgical Time, All Resident Levels
timeFrame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
measure: Skin Closure Time, All Resident Levels
timeFrame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
Secondary outcomes:
measure: Total Number of Participants With Postoperative Complications
timeFrame: From the day of the procedure (Day 1) for 6 weeks
measure: Participants With Postoperative Complications, by Type
timeFrame: From the day of the procedure (Day 1) for 6 weeks
measure: Postoperative Pain
timeFrame: From day of procedure until end of hospital stay (typical dismissal on day 4)
measure: Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
timeFrame: From day of procedure until end of hospital stay (typical dismissal on day 4)
measure: Patient Satisfaction
timeFrame: At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment
measure: Surgeon Satisfaction (Per Procedure)
timeFrame: Immediately after the procedure (day 1)
measure: Cosmetic Outcome
timeFrame: Measured at 6 week postoperative appointment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jennifer Tessmer-Tuck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.
citation: Jagger J, Bentley M, Tereskerz P. A study of patterns and prevention of blood exposures in OR personnel. AORN J. 1998 May;67(5):979-81, 983-4, 986-7 passim. doi: 10.1016/s0001-2092(06)62623-9.
citation: Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8.
citation: Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
citation: Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.