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Completed

NCT Number: NCT01217567

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

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.

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Key information

Conditions

Cesarean Section Cicatrix Fibrosis Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynaechology and Obstetrics, Holbæk Sygehus

Holbæk, 4300, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Preferred side of the caesarean section scar

    Time frame: 6 months postoperatively

    Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.

Secondary outcomes

  1. The difference in pain between the two ends of the scar

    Time frame: 1 and 7 days postoperatively

    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.

  2. The difference in pain between the two ends of the scar

    Time frame: 3 and 6 months postoperatively

    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. Pain in the two ends of the scar

    Time frame: 1 and 7 days postoperatively

    Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.

  4. Pain in the two ends of the scar

    Time frame: 3 and 6 months postoperatively

    Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.

  5. Infection

    Time frame: 7 days postoperatively

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

  6. Infection

    Time frame: 3 and 6 months postoperatively

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

  7. Cosmetic objective evaluation of the two ends of the scar

    Time frame: 6 months postoperatively

    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.

  8. Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.

    Time frame: 6 months

    Primay and Secondary outcome measures are compared in the two groups of patients.

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Region Zealand
  • University of Copenhagen

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 8, 2010
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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