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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margaret L. Dow, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01753518
First received: December 5, 2012
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
The Primary Focus of This Study is to Determine Which Technique of Skin Closure is Superior
Device: Subcuticular suture
Device: Subcuticular staple

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Operating time [ Time Frame: Measured at the time of the procedure (day 1) ] [ Designated as safety issue: No ]

    The primary outcome for this trial is operating time, which will be assessed by two variables -

    1. Total surgical time from incision start to incision completion
    2. Subcuticular skin closure time


Secondary Outcome Measures:
  • Complications [ Time Frame: From the day of the procedure (Day 1) for 6 weeks ] [ Designated as safety issue: Yes ]

    Wound complications, measured by:

    1. Incidence of post-operative suture trimming and staple expulsion
    2. Incidence of superficial wound infection (cellulitis) in the first 6 weeks post-operatively
    3. Incidence of subcutaneous wound complications (including seroma and hematoma) in the first 6 weeks post-operatively
    4. Incidence of fascial wound dehiscence in the first 6 weeks post-operatively

  • Needlestick injury [ Time Frame: On the day of the procedure (day 1) ] [ Designated as safety issue: Yes ]
    Incidence of surgical staff needlestick injury at the time of suture or staple placement.

  • Postoperative pain [ Time Frame: From day of procedure until end of hospital stay (typical dismissal on day 4) ] [ Designated as safety issue: No ]
    Assessment of patient post-operative pain

  • Patient satisfaction [ Time Frame: At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment ] [ Designated as safety issue: No ]
    Patient satisfaction will be measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam.

  • Surgeon satisfaction [ Time Frame: Immediately after the procedure (day 1) ] [ Designated as safety issue: No ]
    Surgeon satisfaction will be assessed by questionnaire immediately after performing the procedure.

  • Cosmetic outcome [ Time Frame: Measured at 6 week postoperative appointment ] [ Designated as safety issue: No ]
    Cosmesis will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam.

  • Cost [ Time Frame: From day of procedure (day 1) to day of hospital discharge (typically day 3 or 4) ] [ Designated as safety issue: No ]
    The cost of each closure technique will be evaluated by considering the cost of the device as well as the cost of OR time, length of hospital stay, and analgesic use.


Enrollment: 220
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcuticular suture
Subcuticular suture has been used for many years to close skin incisions.
Device: Subcuticular suture
Other Name: 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
Other Name: Insorb

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753518

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Margaret L. Dow, M.D.
Investigators
Principal Investigator: Jennifer Tessmer-Tuck, MD Mayo Clinic