Cesarean Trial of Staples vs. Sutures
CROSS
Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)
1 other identifier
interventional
746
1 country
2
Brief Summary
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
November 26, 2019
CompletedNovember 26, 2019
November 1, 2019
4.3 years
September 28, 2010
May 28, 2019
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Wound Complications
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 and readmission for wound complication.
Within 6 weeks of postpartum
Secondary Outcomes (12)
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Patient Satisfaction With Closure Method and Scar Appearance
Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Pain Perception
Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean
Additional Provider Visits
Within 6 weeks postpartum
Number of Participants With Primary Versus Repeat Cesarean
At randomization.
- +7 more secondary outcomes
Study Arms (2)
Staples
ACTIVE COMPARATORInterrupted Ethicon Staples
Suture
ACTIVE COMPARATORSubcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Interventions
Eligibility Criteria
You may qualify if:
- Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Jefferson Universitylead
- Main Line Healthcollaborator
Study Sites (2)
Yale University
New Haven, Connecticut, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Related Publications (6)
Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
PMID: 19254586BACKGROUNDFrishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
PMID: 9350017BACKGROUNDAlderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.
PMID: 12804476BACKGROUNDBasha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
PMID: 20816153BACKGROUNDMackeen AD, Khalifeh A, Fleisher J, Han C, Leiby B, Berghella V. Pain Associated With Cesarean Delivery Skin Closure: A Randomized Controlled Trial. Obstet Gynecol. 2015 Oct;126(4):702-707. doi: 10.1097/AOG.0000000000001043.
PMID: 26348166DERIVEDMackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227.
PMID: 24807325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. A. Dhanya Mackeen
- Organization
- Geisinger
Study Officials
- PRINCIPAL INVESTIGATOR
A. Dhanya Mackeen, MD, MPH
Thomas Jefferson University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 29, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
November 26, 2019
Results First Posted
November 26, 2019
Record last verified: 2019-11