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

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753518
• Other study ID #: 12-003183
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: April 14, 2015
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Device:
• Subcuticular suture
subcuticular Monocryl suture closure
• Subcuticular staple
subcuticular staple wound closure with INSORB 20 device

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Margaret L. Dow, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. Review. — View 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. — View Citation

Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. Review. — View 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):682-90. doi: 10.1097/AOG.0b013e31820ad61e. Review. Erratum in: Obstet Gynecol. 2011 Jun;117(6):1440. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Surgical Time, All Resident Levels	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).	Measured at the time of the procedure (day 1), approximately 1 hour after incision start	No
Primary	Skin Closure Time, All Resident Levels	Measured for all resident education levels (1 to 4 years postgraduate).	Measured at the time of the procedure (day 1), approximately 1 hour after incision start	No
Secondary	Total Number of Participants With Postoperative Complications	Postoperative complications were assessed by chart review.	From the day of the procedure (Day 1) for 6 weeks	Yes
Secondary	Participants With Postoperative Complications, by Type	Postoperative complications were assessed by chart review.	From the day of the procedure (Day 1) for 6 weeks	No
Secondary	Postoperative Pain	Post-operative pain was assessed by pain medication use through chart review.	From day of procedure until end of hospital stay (typical dismissal on day 4)	No
Secondary	Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic	Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .	From day of procedure until end of hospital stay (typical dismissal on day 4)	No
Secondary	Patient Satisfaction	Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).	At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment	No
Secondary	Surgeon Satisfaction (Per Procedure)	Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision?" "How willing are you to recommend this skin closure (whether it was staples or suture) to a patient?" "How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section?" There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with "not at all,' "not very," and "no opinion" being a negative response, and "somewhat" and "extremely " being a positive response. Categories reported were negative, (including no opinion), and positive.	Immediately after the procedure (day 1)	No
Secondary	Cosmetic Outcome	The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.	Measured at 6 week postoperative appointment	No