Postoperative Pain and Skin Closure Methods After Cesarean Section

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Dr. Joshua Nitsche, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT02028000
First received: October 9, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

The study is looking at women undergoing cesarean section delivery of their baby. The purpose of this research study is to determine what type of skin closure after cesarean section helps decrease pain level the most and improves the appearance of the incision site.

The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain.

Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.


Condition Intervention
Pregnancy
Procedure: Insorb staples skin closure
Procedure: Monocryl skin closure
Procedure: Vicryl skin closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Post-Operative Pain and Skin Closure Methods After Cesarean Section

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Intravenous and analgesic use. [ Time Frame: Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks ] [ Designated as safety issue: No ]
    Record the amount of in hospital intravenous and oral analgesic use.

  • Daily subjective pain score while hospitalized [ Time Frame: Hospital admission for cesarean section delivery ] [ Designated as safety issue: No ]
    Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded.

  • 6 week postoperative subjective pain score [ Time Frame: After cesarean section delivery at the 6 week postpartum visit ] [ Designated as safety issue: No ]
    Patient rated subjective pain score 6 weeks postoperatively will be recorded.

  • Scar cosmetic score 6 weeks post-operatively. [ Time Frame: 6 weeks post-operatively after cesarean section ] [ Designated as safety issue: No ]
    6 weeks post-operative scar cosmetic score will be recorded.


Secondary Outcome Measures:
  • Wound complications [ Time Frame: Time of cesarean section until 6 weeks postpartum visit ] [ Designated as safety issue: No ]
    Wound complications (infection, separation, or seroma)

  • Length of hospital stay [ Time Frame: C/S admission to discharge time ] [ Designated as safety issue: No ]
    Length of hospital stay


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: INSORB staples skin closure
Women undergoing cesarean section delivery will have skin closure with INSORB staples.
Procedure: Monocryl skin closure
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
Procedure: Vicryl skin closure
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
Active Comparator: Monocryl skin closure
Women undergoing cesarean section delivery will have skin closure with Monocryl.
Procedure: Insorb staples skin closure
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Procedure: Vicryl skin closure
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
Active Comparator: Vicryl skin closure
Women undergoing cesarean section delivery will have Vicryl skin closure
Procedure: Insorb staples skin closure
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Procedure: Monocryl skin closure
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.

Detailed Description:

Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Centers for Disease Control National Vital Statistics Report 32.3% of all births in the United States were via cesarean delivery, marking the twelfth consecutive annual increase in the cesarean delivery rate. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

The topic of skin closure after cesarean delivery is an area that has been the focus of several randomized control trials. The trials compared surgical steel staples to subcuticular suture of various materials focusing on differences in post-operative pain, infection rates, and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and none have found differences between surgical steel staples and subcuticular suture. Infection rate has been studied in a single observational study which found a higher infection rate in those patients whose skin was closed with surgical steel staples compared to suture. Studies of post-operative pain and skin closure technique have been contradictory. The earliest Randomized clinical trial to investigate skin closure and post-operative pain was done by Frishman et al (5) and found that subjective self-assessment of pain was better at hospital discharge and 6 weeks post-operatively in patients when subcuticular suture rather than surgical steel staples were used. A subsequent Randomized clinical trial reported the opposite result with less pain 6 weeks post-operatively when surgical steel staples were used. This discrepancy may, in part, be due to the different suture material used in the two trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the time of cesarean with these two suture materials has not been performed.

Recently, a new technology for skin closure has been introduced that employs absorbable material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this method of skin closure has shown less histological inflammation and fewer wound infections than either surgical steel staples or subcuticular suture. Unfortunately, little is known about how this skin closure technique compares to the other more established techniques after cesarean delivery in humans. However, a retrospective analysis comparing subcuticular absorbable staples with surgical steel staples revealed an association between subcuticular absorbable staples and decreased in-hospital analgesic use. The current study is a prospective randomized trial that investigates four cesarean skin closure techniques—surgical steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples—to determine if one is associated with improved cosmesis or a decrease in post-operative pain.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-44
  • Any race
  • Any parity
  • Scheduled Cesarean Section
  • Neuraxial analgesia

Exclusion Criteria:

  • Diabetes Mellitus
  • Maternal Connective Tissue Disorder
  • Maternal Steroid Use
  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: NCT02028000

Contacts
Contact: Joshua Nitsche, MD, PhD 336-716-1025 jnitsche@wakehealth.edu
Contact: Kristi Lanier, RN 336-718-5344 klanier@wakehealth.edu

Locations
United States, North Carolina
Forsyth Medical Center Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Joshua Nitsche, MD, PhD    336-716-1025    jnitsche@wakehealth.edu   
Contact: Kristi Lanier, RN    336-718-5344    klanier@wakehealth.edu   
Principal Investigator: Joshua Nitsche, MD, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Joshua Nitsche, MD, PhD Wake Forest Baptist School of Medicine
  More Information

Publications:

Responsible Party: Dr. Joshua Nitsche, Assistant professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT02028000     History of Changes
Other Study ID Numbers: 17928
Study First Received: October 9, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Pregnancy
Pregnant
Cesarean Section Delivery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014