Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
|Pregnancy Cesarean Section||Procedure: Staples Procedure: Prolene non-absorbable sutures Procedure: Absorbable Sutures||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study|
- Pain levels during the post-operative hospitalization period and at time of staple or suture removal. [ Time Frame: Third to fourth post operative day. ]
- Pain at 6 weeks post op [ Time Frame: 6 weeks post op ]
- Wound complications (infection, seroma/hematoma, dehiscence) [ Time Frame: 6 weeks post op ]
- Patient satisfaction at post operative day 3, 4 and 6 weeks [ Time Frame: 6 weeks post op ]
- Operative room time [ Time Frame: Time of skin incision to time of skin closure ]
- Removal time [ Time Frame: Post operative day 3 or 4 ]
- Overall cosmesis [ Time Frame: 6 weeks post op ]A zero to 5 scale cosmesis score. Zero being worst and 5 being best appearance.
- Overall patient satisfaction [ Time Frame: 6 weeks post op ]Patient questionnaires completed at post op day 1, post op day 3 or 4 and 6 weeks post partum.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Staples
Use of staples for skin closure at cesarean section
Staples for closure of cesarean section skin incision
Other Name: Reflex one skin stapler 35 wide. Manufactured by Conmed
Active Comparator: Prolene non-absorbable sutures
Use of Prolene non-absorbable sutures for skin closure at cesarean section
Procedure: Prolene non-absorbable sutures
Prolene non-absorbable sutures for closure of cesarean skin incision
Other Name: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon
Active Comparator: Absorbable sutures
Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.
Procedure: Absorbable Sutures
Absorbable sutures for closure of cesarean skin incision
Other Name: Monocryl or Vicryl. Manufactured by Ethicon
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.
When a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.
Pain level will be assessed on the first and third or fourth day after surgery and again at six weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509950
|Contact: Natali Aziz, MDfirstname.lastname@example.org|
|Contact: Anna Girsen, PhDemail@example.com|
|United States, California|
|Lucile Packard Childrens Hospital||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Natali Aziz, MD 650-724-8222 firstname.lastname@example.org|
|Principal Investigator:||Natali Aziz, MD||Stanford University|