Cesarean Trial of Staples vs. Sutures (CROSS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Main Line Health
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01211600
First received: September 28, 2010
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.


Condition Intervention
Cesarean Section
Wound Complications
Patient Satisfaction
Pain Measurement
Other: Staples
Other: Suture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Wound complications [ Time Frame: 4 - 8 weeks after intervention of staples or stitches. ] [ Designated as safety issue: No ]

    The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture.

    Wound complications included infection, hematoma, seroma, and separation.



Secondary Outcome Measures:
  • Cosmesis [ Time Frame: Immediately postpartum and 4 - 8 weeks after intervention. ] [ Designated as safety issue: No ]
    Whether physician and patient evaluation of cosmesis of the cesarean incision differed from each other and whether the evaluation differed based on closure method: staples vs sutures.

  • Patient satisfaction [ Time Frame: Immediately postpartum and 4 - 8 weeks after intervention. ] [ Designated as safety issue: No ]
    Whether the patient's satisfaction with the incison differed based on closure method: staples vs sutures.

  • Pain perception [ Time Frame: Immediately postpartum and 4 - 8 weeks after intervention. ] [ Designated as safety issue: No ]
    Whether the patient's perception of pain associated with the incison differed based on closure method: staples vs sutures.

  • Cost [ Time Frame: 4 - 8 weeks after intervention. ] [ Designated as safety issue: No ]
    Cost analysis to compare the two closure techniques, including additional office visits.

  • Additional provider visits [ Time Frame: 4 - 8 weeks post intervention. ] [ Designated as safety issue: No ]
    We will also note whether the patient was evaluated by a provider for a wound concern prior to the scheduled 4-6 week postpartum visit despite not being diagnosed with one of the aforementioned wound complications.

  • Wound complications - additional analyses [ Time Frame: 4 - 8 weeks after intervention ] [ Designated as safety issue: No ]
    We will also compare wound complications rates between staples and suture with respect to: length of time until staple removal (between days 4 and 10), type of suture used (Monocryl vs. Vicryl), timing of the Cesarean (prior to labor versus after the onset of labor), presence or absence of chorioamnionitis, total operative time for skin closure, gestational age at delivery, and placement of incision with regards to the pannus.


Estimated Enrollment: 936
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Staples
Interrupted Ethicon Staples
Other: Staples
Interrupted Ethicon Staples
Other Name: Closure Technique
Active Comparator: Suture
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Other: Suture
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Other Name: Closure Technique

Detailed Description:

Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion Criteria:

  • Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery),
  • Vertical skin incisions
  • Chronic steroid use
  • Active lupus flare
  • HIV/AIDS
  • Current treatment for cancer or a history of radiation to the abdomen/pelvis
  • Current treatment with immunosuppressant medications secondary to history of transplantation
  • Emergency cesarean(precluding informed consent prior to surgery)
  • Lack of access to a phone
  • Allergy to suture or staple material
  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: NCT01211600

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Main Line Health
Investigators
Principal Investigator: A. Dhanya Mackeen, MD, MPH Thomas Jefferson University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01211600     History of Changes
Other Study ID Numbers: 10D.199
Study First Received: September 28, 2010
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Staples
Sutures
Wound infections
Cosmesis
Aesthetic appearance of skin incision

ClinicalTrials.gov processed this record on October 22, 2014