Lucile Packard Childrens Hospital
Palo Alto, California, 94304, United States
NCT Number: NCT01509950
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, Absorbable suture (monocryl or vicryl) or 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.
Looking for future studies?
Notify Me18 year–55 year
Female
Interventional
Not applicable
Palo Alto, California, 94304, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Staples for closure of cesarean section skin incision
Other names: Reflex one skin stapler 35 wide. Manufactured by Conmed
Prolene non-absorbable sutures for closure of cesarean skin incision
Other names: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon
Absorbable sutures for closure of cesarean skin incision
Other names: Monocryl or Vicryl. Manufactured by Ethicon
Time frame: Post-operative day 3 or 4.
Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)
Time frame: Post-operative week 6
Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).
Time frame: Post-operative week 6
Wound complications include conditions like infection, seroma/hematoma and dehiscence
Time frame: Post-operative day 3 or 4
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Time frame: Post-operative week 6
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Time frame: Day of cesarean delivery (up to 8 hours)
Measured in minutes
Time frame: Post-operative day 3 or 4
Measured in seconds
Time frame: Post-operative week 6
Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)
Time frame: Post-operative day 1
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Time frame: Post-operative day 3 or 4
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Time frame: Post-operative week 6
Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)
Stanford University
Other
Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07406373
Cesarean Section, Elective Cesarean Section
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT05033041
Aspiration, Cesarean Section
Chicago, Illinois, United States
View Trial DetailsNCT05736341
Cesarean Section, Pregnancy
Seoul, South Korea
View Trial DetailsNCT06119971
Cesarean Section, Pregnancy
Tours, France
View Trial Details