Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.
NCT ID: NCT01217567
Last Updated: 2012-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-03-31
2012-01-31
Brief Summary
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1. An objective evaluation of the two ends of the scar 6 months postoperatively.
2. A patient evaluation of the two ends of the scar 6 months postoperatively.
3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).
4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.
5. The rate of infection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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1st c-section, no previous lower abdominal surgery - s.l.
Staples left, subcuticular suture right
Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
Woman with previous ceasarean section - staples left
Staples left, subcuticular suture right
Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
1st c-section, no previous lower abdominal surgery
Subcuticular suture left side and staples right
Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
Woman with previous ceasarean section
Subcuticular suture left side and staples right
Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
Interventions
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Staples left, subcuticular suture right
Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
Subcuticular suture left side and staples right
Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
Eligibility Criteria
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Inclusion Criteria
* Woman who speak and understand Danish
* Woman who can give informed consent.
Exclusion Criteria
* Diabetics (this does not include gestational diabetes).
* Infection
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Age under 18
* Chronic pain disease eg fibromyalgia, rheumatoid arthritis
* BMI over 35
* Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).
18 Years
FEMALE
Yes
Sponsors
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University of Copenhagen
OTHER
Region Zealand
OTHER
Holbaek Sygehus
OTHER
Responsible Party
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Anna Aabakke
Anna Aabakke, M.D.
Principal Investigators
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Niels Jørgen Secher, Profesoor, M.D.
Role: STUDY_CHAIR
Department of Obstetrics, Hvidovre Hospital
Anna J. M. Aabakke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Gynaechology and Obstetrics, Holbæk Sygehus
Locations
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Department of Gynaechology and Obstetrics, Holbæk Sygehus
Holbæk, , Denmark
Countries
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References
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The CAESAR study: http://www.npeu.ox.ac.uk/caesar
Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8.
CORONIS Trial Collaborative Group. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy Childbirth. 2007 Oct 22;7:24. doi: 10.1186/1471-2393-7-24.
Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.
Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
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.
Alderdice 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.
Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.
Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.
Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3.
Other Identifiers
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SJ-162
Identifier Type: OTHER
Identifier Source: secondary_id
Cicatricestudiet
Identifier Type: -
Identifier Source: org_study_id
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