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Cesarean Trial of Staples vs. Sutures (CROSS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Thomas Jefferson University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211600
First Posted: September 29, 2010
Last Update Posted: February 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Main Line Health
Information provided by (Responsible Party):
Thomas Jefferson University
  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 (Outcomes Assessor)
Official Title: Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)

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. ]

    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. ]
    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. ]
    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. ]
    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. ]
    Cost analysis to compare the two closure techniques, including additional office visits.

  • Additional provider visits [ Time Frame: 4 - 8 weeks post intervention. ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: September 28, 2010
First Posted: September 29, 2010
Last Update Posted: February 6, 2014
Last Verified: February 2014

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