Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
NCT ID: NCT02838017
Last Updated: 2019-08-14
Study Results
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View full resultsBasic Information
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TERMINATED
NA
504 participants
INTERVENTIONAL
2016-11-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tissue Adhesive
Tissue Adhesive will be placed over subcuticular suture closure.
Tissue Adhesive
Steri-Strips
Sterile strips will be placed over subcuticular suture closure.
Sterile strips
Interventions
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Tissue Adhesive
Sterile strips
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Planned use of staples for skin closure
* Unavailability of research personnel to accomplish consent and randomization at the time of cesarean
FEMALE
Yes
Sponsors
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University of Chicago
OTHER
Endeavor Health
OTHER
Responsible Party
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Beth Plunkett
Clinical Associate Professor, Maternal & Fetal Medicine, Obstetrics & Gynecology
Principal Investigators
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Beth Plunkett, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Lena Braginsky, MD
Role: STUDY_DIRECTOR
Endeavor Health
Locations
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University of Chicago
Chicago, Illinois, United States
NorthShore Evanston Hospital
Evanston, Illinois, United States
NorthShore Highland Park Hospital
Highland Park, Illinois, United States
Countries
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References
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Souza EC, Fitaroni RB, Januzelli DM, Macruz HM, Camacho JC, Souza MR. Use of 2-octyl cyanoacrylate for skin closure of sternal incisions in cardiac surgery: observations of microbial barrier effects. Curr Med Res Opin. 2008 Jan;24(1):151-5. doi: 10.1185/030079908x253807.
Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.
Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384.
Tipton AM, Cohen SA, Chelmow D. Wound infection in the obese pregnant woman. Semin Perinatol. 2011 Dec;35(6):345-9. doi: 10.1053/j.semperi.2011.05.020.
Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.
Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30.
Braginsky L, Javellana M, Cleveland E, Elue R, Wang C, Boyle D, Plunkett BA. Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):295-301. doi: 10.1097/AOG.0000000000003367.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EH16-095
Identifier Type: -
Identifier Source: org_study_id
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