Sharp Versus Blunt Fascial Incision at Caesarean Section

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

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

Conditions
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Cesarean Section

Intervention / Treatment
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* Procedure: Blunt right, sharp left
* Procedure: Blunt left, sharp right


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right sharp, left blunt<br>Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline. | Procedure: Blunt left, sharp right<br>* Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.<br>|
| Experimental: Right blunt, left sharp<br>Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline. | Procedure: Blunt right, sharp left<br>* Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred side of the scar evaluated by the patient 3 months postoperatively | The overall preference of scar side - left, right or no difference - taking the entire postoperative 3 months into account as evaluated by the patient. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pain between the two sides of the scar | 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. | 1, 3 and 7 days postoperatively | 
| The difference in pain between the two sides of the scar | 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. | 1 and 3 months postoperatively | 
| Pain on the two sides of the scar | 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. | 1, 3 and 7 days postoperatively | 
| Pain in the two sides of the scar | 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. | 1 and 3 months postoperatively | 
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 7 days | 
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 1 and 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Cesarean section[*methods], Fascia [*surgery], Randomized Controlled Trial, Abdominal Wall [*surgery], Pain, postoperative, Surgical wound infection