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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cicatrix; Cesarean Section
• Intervention / Treatment: Procedure: Staples left, subcuticular suture right; Procedure: Subcuticular suture left side and staples right

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holbæk, Denmark, 4300
    • Department of Gynaechology and Obstetrics, Holbæk Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1st c-section, no previous lower abdominal surgery - s.l.	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.
Experimental: Woman with previous ceasarean section - staples left	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.
Experimental: 1st c-section, no previous lower abdominal surgery	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.
Experimental: Woman with previous ceasarean section	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in pain between the two ends of the scar	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.	1 and 7 days postoperatively
The difference in pain between the two ends of the scar	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.	3 and 6 months postoperatively
Pain in the two ends of the scar	Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.	1 and 7 days postoperatively
Pain in the two ends of the scar	Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.	3 and 6 months postoperatively
Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	7 days postoperatively
Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	3 and 6 months postoperatively
Cosmetic objective evaluation of the two ends of the scar	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.	6 months postoperatively
Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.	Primay and Secondary outcome measures are compared in the two groups of patients.	6 months

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: University of Copenhagen; Region Zealand
• Investigators: Study Chair: Niels Jørgen Secher, Profesoor, M.D., Department of Obstetrics, Hvidovre Hospital; Principal Investigator: Anna J. M. Aabakke, M.D., Department of Gynaechology and Obstetrics, Holbæk Sygehus

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Infection; cesarean section; postoperative pain; cicatrix; sutures; surgical staples
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: Cicatricestudiet; SJ-162 (Other Identifier: The Danish National Committee on Biomedical Research Ethics)