Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2011

Interventions

  • Procedure: 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.
  • Procedure: 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.

Arms, Groups and Cohorts

  • Experimental: 1st c-section, no previous lower abdominal surgery – s.l.
  • Experimental: Woman with previous ceasarean section – staples left
  • Experimental: 1st c-section, no previous lower abdominal surgery
  • Experimental: Woman with previous ceasarean section

Clinical Trial Outcome Measures

Primary Measures

  • Preferred side of the caesarean section scar
    • Time Frame: 6 months postoperatively
    • Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.

Secondary Measures

  • The difference in pain between the two ends of the scar
    • Time Frame: 1 and 7 days postoperatively
    • Difference in painscore between the two ends of the scar 1st and 7th postoperative day. Pain is registered by a score on a vas-scale from 0-10.
  • The difference in pain between the two ends of the scar
    • Time Frame: 3 and 6 months postoperatively
    • Difference in painscore between the two ends of the scar 3 and 6 months postoperatively. Pain is registered by a score on a vas-scale from 0-10.
  • Pain in the two ends of the scar
    • Time Frame: 1 and 7 days postoperatively
    • Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.
  • Pain in the two ends of the scar
    • Time Frame: 3 and 6 months postoperatively
    • Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.
  • Infection
    • Time Frame: 7 days postoperatively
    • The rate of postoperative infection and what side of the scar – right or left -that is infected.
  • Infection
    • Time Frame: 3 and 6 months postoperatively
    • The rate of postoperative infection and what side of the scar – right or left -that is infected.
  • Cosmetic objective evaluation of the two ends of the scar
    • Time Frame: 6 months postoperatively
    • Evaluation of the right and left side of the scar respectively by two blinded doctors using the Singer’s “scar evaluation scale” . Difference in Singer’s score between the two ends of the scar.
  • Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.
    • Time Frame: 6 months
    • Primay and Secondary outcome measures are compared in the two groups of patients.

Participating in This Clinical Trial

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).

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Holbaek Sygehus
  • Collaborator
    • University of Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Aabakke, Anna Aabakke, M.D. – Holbaek Sygehus
  • Overall Official(s)
    • Niels Jørgen Secher, Profesoor, M.D., Study Chair, Department of Obstetrics, Hvidovre Hospital
    • Anna J. M. Aabakke, M.D., Principal Investigator, Department of Gynaechology and Obstetrics, Holbæk Sygehus

References

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.

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