A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

NCT ID: NCT01753518

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Surgical Wound

Keywords

Subcuticular suture; Subcuticular staple; Skin closure; Incision closure; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subcuticular suture

Subcuticular suture has been used for many years to close skin incisions.

Group Type: ACTIVE_COMPARATOR

Subcuticular suture

Intervention Type: DEVICE

subcuticular Monocryl suture closure

Subcuticular staple

Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.

Group Type: ACTIVE_COMPARATOR

Subcuticular staple

Intervention Type: DEVICE

subcuticular staple wound closure with INSORB 20 device

Interventions

Subcuticular suture

subcuticular Monocryl suture closure

Intervention Type: DEVICE

Subcuticular staple

subcuticular staple wound closure with INSORB 20 device

Intervention Type: DEVICE

Other Intervention Names

Monocryl; Insorb

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Margaret L. Dow, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Margaret L. Dow, M.D.

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Tessmer-Tuck, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21343772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9592605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14520211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16260200 (View on PubMed)

Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.

Reference Type: BACKGROUND

PMID: 20216417 (View on PubMed)

Other Identifiers

12-003183

Identifier Type: -

Identifier Source: org_study_id