Cesarean Trial of Staples vs. Sutures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-12-31

Brief Summary

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To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

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Detailed Description

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Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.

Conditions

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Cesarean Section Wound Complications Patient Satisfaction Pain Measurement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Staples

Interrupted Ethicon Staples

Group Type ACTIVE_COMPARATOR

Staples

Intervention Type OTHER

Interrupted Ethicon Staples

Suture

Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type OTHER

Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Interventions

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Staples

Interrupted Ethicon Staples

Intervention Type OTHER

Suture

Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Intervention Type OTHER

Other Intervention Names

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Closure Technique Closure Technique

Eligibility Criteria

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Inclusion Criteria

* Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion Criteria

* Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels \> 95 and 120 respectively within the week prior to delivery),
* Vertical skin incisions
* Chronic steroid use
* Active lupus flare
* HIV/AIDS
* Current treatment for cancer or a history of radiation to the abdomen/pelvis
* Current treatment with immunosuppressant medications secondary to history of transplantation
* Emergency cesarean(precluding informed consent prior to surgery)
* Lack of access to a phone
* Allergy to suture or staple material

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes