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Completed

NCT Number: NCT01297725

Sharp Versus Blunt Fascial Incision at Caesarean Section

The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:

1. The preferred side evaluated by the patient 3 months postoperatively. 2. The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively. 3. The rate and side of infection.

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Key information

Conditions

Cesarean Section Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynaechology and Obstetrics, Holbaek Hospital, Holbæk, Denmark

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Woman having caesarean section for the first time
  • Woman, who have had no previous lower abdominal surgery
  • Woman who speak and understand Danish
  • Woman who can give informed consent

Exclusion criteria

  • Diabetes Mellitus (This does not include gestational diabetes)
  • Infection
  • Regular treatment with immunosuppressives
  • Alcohol or drug abuse
  • Age under 18 years old
  • Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
  • BMI over 35

Treatment and study plan

Blunt right, sharp left

Procedure

Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.

Blunt left, sharp right

Procedure

Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.

Primary outcomes

  1. Preferred side of the scar evaluated by the patient 3 months postoperatively

    Time frame: 3 months

    The overall preference of scar side - left, right or no difference - taking the entire postoperative 3 months into account as evaluated by the patient.

Secondary outcomes

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

    Time frame: 1, 3 and 7 days postoperatively

    Difference in painscore between the two ends of the scar on the 1st, 2nd 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 sides of the scar

    Time frame: 1 and 3 months postoperatively

    Description: Difference in painscore between the two ends of the scar one and three months postoperatively. Pain is registered by a score on a vas-scale from 0-10.

  3. Pain on the two sides of the scar

    Time frame: 1, 3 and 7 days postoperatively

    Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1, 3 and 7 days postoperatively.

  4. Pain in the two sides of the scar

    Time frame: 1 and 3 months postoperatively

    Pain in the two sides of the scar is registered by a score on a vas-scale from 0-10 1 and 3 months postoperatively.

  5. Infection

    Time frame: 7 days

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

  6. Infection

    Time frame: 1 and 3 months postoperatively

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

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

Sharp Versus Blunt Fascial Incision at Caesarean Section: A Prospective Randomized Double-blinded Case-Control Study With the Case as it's Own Control.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2011
Registry last updated
Oct 19, 2011

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

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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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