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

Primary Purpose

Cesarean Section, Cicatrix

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Staples left, subcuticular suture right
Subcuticular suture left side and staples right
Sponsored by
Holbaek Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section focused on measuring cicatrix, cesarean section, sutures, surgical staples, postoperative pain, Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Gynaechology and Obstetrics, Holbæk Sygehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Woman with previous ceasarean section - staples left

1st c-section, no previous lower abdominal surgery

Woman with previous ceasarean section

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Infection
The rate of postoperative infection and what side of the scar - right or left -that is infected.
Infection
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
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.
Primay and Secondary outcome measures are compared in the two groups of patients.

Full Information

First Posted
October 7, 2010
Last Updated
February 7, 2012
Sponsor
Holbaek Sygehus
Collaborators
University of Copenhagen, Region Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT01217567
Brief Title
Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holbaek Sygehus
Collaborators
University of Copenhagen, Region Zealand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Cicatrix
Keywords
cicatrix, cesarean section, sutures, surgical staples, postoperative pain, Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1st c-section, no previous lower abdominal surgery - s.l.
Arm Type
Experimental
Arm Title
Woman with previous ceasarean section - staples left
Arm Type
Experimental
Arm Title
1st c-section, no previous lower abdominal surgery
Arm Type
Experimental
Arm Title
Woman with previous ceasarean section
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Staples left, subcuticular suture right
Intervention Description
Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
Intervention Type
Procedure
Intervention Name(s)
Subcuticular suture left side and staples right
Intervention Description
Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
Primary Outcome Measure Information:
Title
Preferred side of the caesarean section scar
Description
Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
The difference in pain between the two ends of the scar
Description
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.
Time Frame
1 and 7 days postoperatively
Title
The difference in pain between the two ends of the scar
Description
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.
Time Frame
3 and 6 months postoperatively
Title
Pain in the two ends of the scar
Description
Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.
Time Frame
1 and 7 days postoperatively
Title
Pain in the two ends of the scar
Description
Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.
Time Frame
3 and 6 months postoperatively
Title
Infection
Description
The rate of postoperative infection and what side of the scar - right or left -that is infected.
Time Frame
7 days postoperatively
Title
Infection
Description
The rate of postoperative infection and what side of the scar - right or left -that is infected.
Time Frame
3 and 6 months postoperatively
Title
Cosmetic objective evaluation of the two ends of the scar
Description
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.
Time Frame
6 months postoperatively
Title
Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.
Description
Primay and Secondary outcome measures are compared in the two groups of patients.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Jørgen Secher, Profesoor, M.D.
Organizational Affiliation
Department of Obstetrics, Hvidovre Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna J. M. Aabakke, M.D.
Organizational Affiliation
Department of Gynaechology and Obstetrics, Holbæk Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynaechology and Obstetrics, Holbæk Sygehus
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark

12. IPD Sharing Statement

Citations:
Citation
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Results Reference
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Citation
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18336721
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.
Results Reference
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PubMed Identifier
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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):514-520. doi: 10.1016/S1701-2163(16)34213-X.
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PubMed Identifier
9350017
Citation
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Citation
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Results Reference
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Citation
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Results Reference
derived

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

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