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

Cesarean Section Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217567
• Other study ID #: Cicatricestudiet
• Secondary ID: SJ-162
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: February 7, 2012
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Section
• Cicatrix

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Gynaechology and Obstetrics, Holbæk Sygehus	Holbæk

Sponsors (3)

Lead Sponsor	Collaborator
Holbaek Sygehus	Region Zealand, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD003577. — View 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):514-20. Review. — View 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. — View 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. — View 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. — View 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. Epub 2007 Sep 6. — View Citation

Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. Review. — View Citation

Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. Epub 2006 Jul 5. — View 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. — View 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):1892-7. — View Citation

The CAESAR study: http://www.npeu.ox.ac.uk/caesar

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	7 days postoperatively	No
Secondary	Infection	The rate of postoperative infection and what side of the scar - right or left -that is infected.	3 and 6 months postoperatively	No
Secondary	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	No
Secondary	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	No