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

April 14, 2015 updated by: Margaret L. Dow, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Subcuticular suture
Subcuticular suture has been used for many years to close skin incisions.
Device: Subcuticular suture
subcuticular Monocryl suture closure
Other Names:
  • Monocryl
ACTIVE_COMPARATOR: Subcuticular staple
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
Device: Subcuticular staple
subcuticular staple wound closure with INSORB 20 device
Other Names:
  • Insorb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured at the time of the procedure (day 1), approximately 1 hour after incision start
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).
Measured at the time of the procedure (day 1), approximately 1 hour after incision start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Participants With Postoperative Complications
Time Frame: From the day of the procedure (Day 1) for 6 weeks
Postoperative complications were assessed by chart review.
From the day of the procedure (Day 1) for 6 weeks
Participants With Postoperative Complications, by Type
Time Frame: From the day of the procedure (Day 1) for 6 weeks
Postoperative complications were assessed by chart review.
From the day of the procedure (Day 1) for 6 weeks
Postoperative Pain
Time Frame: From day of procedure until end of hospital stay (typical dismissal on day 4)
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)
Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
Time Frame: From day of procedure until end of hospital stay (typical dismissal on day 4)
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)
Patient Satisfaction
Time Frame: At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment
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
Surgeon Satisfaction (Per Procedure)
Time Frame: Immediately after the procedure (day 1)
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)
Cosmetic Outcome
Time Frame: Measured at 6 week postoperative appointment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Margaret L. Dow, M.D.

Investigators

  • Principal Investigator: Jennifer Tessmer-Tuck, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-003183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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