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

Holbaek Sygehus

Status: Completed

Conditions: Cicatrix; Cesarean Section

Treatments: Procedure: Staples left, subcuticular suture right; Procedure: Subcuticular suture left side and staples right

Study type: Interventional

Funder types: Other

Identifiers

NCT01217567

Cicatricestudiet

SJ-162 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

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

Experimental group

Treatment:

Procedure: Staples left, subcuticular suture right

Woman with previous ceasarean section - staples left

Experimental group

Treatment:

Procedure: Staples left, subcuticular suture right

1st c-section, no previous lower abdominal surgery

Experimental group

Treatment:

Procedure: Subcuticular suture left side and staples right

Woman with previous ceasarean section

Experimental group

Treatment:

Procedure: Subcuticular suture left side and staples right