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

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Region Zealand
Information provided by (Responsible Party):
Anna Aabakke, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01217567
First received: October 7, 2010
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention
Cesarean Section
Cicatrix
Procedure: Staples left, subcuticular suture right
Procedure: Subcuticular suture left side and staples right

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Holbaek Sygehus:

Primary Outcome Measures:
  • Preferred side of the caesarean section scar [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.


Secondary Outcome Measures:
  • The difference in pain between the two ends of the scar [ Time Frame: 1 and 7 days postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Primay and Secondary outcome measures are compared in the two groups of patients.


Estimated Enrollment: 60
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217567

Locations
Denmark
Department of Gynaechology and Obstetrics, Holbæk Sygehus
Holbæk, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
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
  More Information

Publications:
Cromi A, Ghezzi F, Gottardi A, Cherubino M, Ucella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol 2010; 203

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Aabakke, Anna Aabakke, M.D., Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT01217567     History of Changes
Other Study ID Numbers: Cicatricestudiet, SJ-162
Study First Received: October 7, 2010
Last Updated: February 7, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Holbaek Sygehus:
cicatrix
cesarean section
sutures
surgical staples
postoperative pain
Infection

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014