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

NCT01217567 | Completed

• 2 other identifiers: CicatricestudietSJ-162
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.An objective evaluation of the two ends of the scar 6 months postoperatively.
2. 2.A patient evaluation of the two ends of the scar 6 months postoperatively.
3. 3.The difference in pain in the two ends of the scar 1 day postoperatively (blinded).
4. 4.The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.
5. 5.The rate of infection.

Conditions

Cesarean Section; Cicatrix

Keywords

cicatrix; cesarean section; sutures; surgical staples; postoperative pain; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The difference in pain between the two ends of the scar

  1 and 7 days postoperatively

• The difference in pain between the two ends of the scar

  3 and 6 months postoperatively

• Pain in the two ends of the scar

  1 and 7 days postoperatively

• Pain in the two ends of the scar

  3 and 6 months postoperatively

• Infection

  7 days postoperatively

Study Arms (4)

1st c-section, no previous lower abdominal surgery - s.l.

EXPERIMENTAL

Procedure: Staples left, subcuticular suture right

Woman with previous ceasarean section - staples left

EXPERIMENTAL

Procedure: Staples left, subcuticular suture right

1st c-section, no previous lower abdominal surgery

EXPERIMENTAL

Procedure: Subcuticular suture left side and staples right

Woman with previous ceasarean section

EXPERIMENTAL

Procedure: Subcuticular suture left side and staples right

Interventions

Staples left, subcuticular suture right PROCEDURE

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 - s.l.; Woman with previous ceasarean section - staples left

Subcuticular suture left side and staples right PROCEDURE

Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.

1st c-section, no previous lower abdominal surgery; Woman with previous ceasarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Holbaek Sygehus: lead
• University of Copenhagen: collaborator
• Region Zealand: collaborator

Study Sites (1)

Department of Gynaechology and Obstetrics, Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Related Publications (12)

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

  BACKGROUND

• 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.

  PMID: 14520211 BACKGROUND

• 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.

  PMID: 18336721 BACKGROUND

• 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.

  PMID: 19646316 BACKGROUND

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

  PMID: 9350017 BACKGROUND

• 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.

  PMID: 17825472 BACKGROUND

• 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.

  PMID: 18090752 BACKGROUND

• 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.

  PMID: 19254586 BACKGROUND

• 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.

  PMID: 12804476 BACKGROUND

• 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.

  PMID: 16822582 BACKGROUND

• 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.

  PMID: 20417924 BACKGROUND

• 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.

  PMID: 24084548 DERIVED

MeSH Terms

Conditions

Cicatrix; Pain, Postoperative; Infections

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Niels Jørgen Secher, Profesoor, M.D.

  Department of Obstetrics, Hvidovre Hospital

  STUDY CHAIR

• Anna J. M. Aabakke, M.D.

  Department of Gynaechology and Obstetrics, Holbæk Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anna Aabakke, M.D.

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

DK (1)