Clinical trial NCT01217567: Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.
Official title: Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section: A Prospective Randomized Single-blinded Case-Control Study With the Case as it's Own Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Cicatrix
Keywords: cicatrix
cesarean section
sutures
surgical staples
postoperative pain
Infection
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Region Zealand
First posted: 2010-10-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered:

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.


Eligibility criteria: Inclusion Criteria:

* Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started.
* Woman who speak and understand Danish
* Woman who can give informed consent.

Exclusion Criteria:

* Level I or II caesarean section (ordered less than 30 min. before surgery is started).
* 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).

Primary outcomes:
measure: Preferred side of the caesarean section scar
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: The difference in pain between the two ends of the scar
timeFrame: 1 and 7 days postoperatively
measure: The difference in pain between the two ends of the scar
timeFrame: 3 and 6 months postoperatively
measure: Pain in the two ends of the scar
timeFrame: 1 and 7 days postoperatively
measure: Pain in the two ends of the scar
timeFrame: 3 and 6 months postoperatively
measure: Infection
timeFrame: 7 days postoperatively
measure: Infection
timeFrame: 3 and 6 months postoperatively
measure: Cosmetic objective evaluation of the two ends of the scar
timeFrame: 6 months postoperatively
measure: Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.
timeFrame: 6 months
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Department of Gynaechology and Obstetrics, Holbæk Sygehus
Study officials:
affiliation: Department of Obstetrics, Hvidovre Hospital
name: Niels Jørgen Secher, Profesoor, M.D.
role: STUDY_CHAIR
affiliation: Department of Gynaechology and Obstetrics, Holbæk Sygehus
name: Anna J. M. Aabakke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: The CAESAR study: http://www.npeu.ox.ac.uk/caesar
citation: 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.
citation: 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.
citation: 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.
citation: Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.