Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture and staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
Procedure: Prolene non-absorbable sutures
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
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. ] [ Designated as safety issue: No ]
- Pain at 6 weeks post op [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
- Wound complications (infection, seroma/hematoma, dehiscence) [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
- Patient satisfaction at post operative day 3, 4 and 6 weeks [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]
- Operative room time [ Time Frame: Time of skin incision to time of skin closure ] [ Designated as safety issue: No ]
- Removal time [ Time Frame: Post operative day 3 or 4 ] [ Designated as safety issue: No ]
- Overall cosmesis [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]A zero to 5 scale cosmesis score. Zero being worst and 5 being best appearance.
- Overall patient satisfaction [ Time Frame: 6 weeks post op ] [ Designated as safety issue: No ]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:||January 2015|
|Estimated Primary Completion Date:||January 2014 (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
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). 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. Both patients 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: Maggi Baumbusch, MDemail@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|