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Sponsored by: |
Thomas Jefferson University |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00293683 |
We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause less pain, have better long-term cosmetic results, and result in improved patient satisfaction over standard metal staples. We expect to see no difference in wound complication rates with these two cesarean skin closure techniques.
Condition | Intervention |
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Cesarean Section |
Device: Insorb absorbable skin staple |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples |
Estimated Enrollment: | 120 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | June 2006 |
Type: Randomized controlled trial
Selection of Patients: All pregnant women, undergoing a primary (their first) cesarean delivery at Thomas Jefferson University Hospital will be offered randomization regardless of indication for cesarean delivery. Patients will be excluded from the study if they have a history of a previous cesarean delivery, history of a previous Pfannensteil skin incision for an indication other than for a cesarean delivery (i.e. myomectomy, laparotomy), or a planned vertical skin incision prior to randomization.
Randomization:
Patients will be randomized to skin closure with either the standard staples or the Insorb™ absorbable staple using a computer-generated random number sequence in blocks of six and ten. Allocation will be concealed in opaque, sealed study envelopes that are held on labor and delivery until after consent is obtained. Patients will not be masked as to the type of stapler used however, the investigator obtaining outcome data at six months will be masked.
Procedure:
The cesarean delivery should be performed in the usual fashion according to the surgeon’s preference.
We recommend:
Skin incisions will be closed with the assigned stapling device. Addison tissue forceps will be used to evert the skin edges. The recommended distance between staples is 8 to 10mm; however this can be altered at the discretion of the operating physician.
Follow Up:
The subject’s age, race, gravidity, parity, reported weight, indication for cesarean delivery, medical co-morbidity, delivery associated complications and findings, charted pain medication and clinic status will be assessed by chart review. Pain, time of placement, patient satisfaction, and cosmetic outcome will be assessed by data sheets filled out by the OR staff, physicians, and patients.
Ages Eligible for Study: | 12 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Jason K. Baxter, MD, MSCP | Thomas Jefferson University |
Study ID Numbers: | 04U.498 |
Study First Received: | February 16, 2006 |
Last Updated: | February 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00293683 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cesarean closure skin |
staple absorbable metal |