Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.

Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.

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Detailed Description

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Conditions

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Surgical Wound Dehiscence Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Negative pressure wound closure

Negative Pressure wound closure

Group Type EXPERIMENTAL

Negative pressure wound closure

Intervention Type PROCEDURE

Applying negative pressure to primary wound closure

Standard wound closure

Standard Wound Closure

Group Type ACTIVE_COMPARATOR

Standard wound closure

Intervention Type PROCEDURE

Standard wound closure

Interventions

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Negative pressure wound closure

Applying negative pressure to primary wound closure

Intervention Type PROCEDURE

Standard wound closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Undergoing Cesarean delivery.
2. Patient at least 18 years of age.
3. Weight greater than 199 pounds.
4. Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.

Exclusion Criteria

1. Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
2. Inability to give proper informed consent.
3. Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
4. Patient less than 18 years of age.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No