Comparison of Staples Versus Prolene Suture for Skin Closure at Cesarean Delivery

Pregnancy Clinical Trial

Official title:

Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509950
• Other study ID #: 22389
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: May 4, 2013

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 4, 2013
• Est. primary completion date: May 4, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Pregnant women undergoing primary or repeat cesarean section

• Maternal age greater than or equal to 18 years of age

• Gestational age greater than or equal to 34 weeks

• Elective and non-elective cesarean section

Exclusion Criteria:

• Type 1 or Type 2 diabetes

• BMI greater than 35

• Pre-operative diagnosis of chorioamnionitis

• History of drug or alcohol abuse

• Contraindication to NSAIDs

• Chronic pain diagnosis

• Narcotic use prior to pregnancy

• Maternal age less than 18 years of age

• General anesthesia

• Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)

• Vertical skin incision

Related Conditions & MeSH terms

• Cesarean Section
• Pregnancy

Intervention

Procedure:
• Staples
Staples for closure of cesarean section skin incision
• Prolene non-absorbable sutures
Prolene non-absorbable sutures for closure of cesarean skin incision
• Absorbable Sutures
Absorbable sutures for closure of cesarean skin incision

Locations

Country	Name	City	State
United States	Lucile Packard Childrens Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Pain on a Scale During the Post-operative Hospitalization Period	Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)	Post-operative day 3 or 4.
Secondary	Level of Pain on a Scale at 6 Weeks Postpartum	Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).	Post-operative week 6
Secondary	Count of Participants With Wound Complications	Wound complications include conditions like infection, seroma/hematoma and dehiscence	Post-operative week 6
Secondary	Level of Patient Satisfaction to the Wound Appearance	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)	Post-operative day 3 or 4
Secondary	Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)	Post-operative week 6
Secondary	Time From Skin Incision to the Skin Closure	Measured in minutes	Day of cesarean delivery (up to 8 hours)
Secondary	Time Needed for the Suture Removal	Measured in seconds	Post-operative day 3 or 4
Secondary	Level of Patient's Satisfaction to the Cosmesis of the Wound	Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)	Post-operative week 6
Secondary	Level of Patient's Overall Patient Satisfaction to the Type of Closure	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)	Post-operative day 1
Secondary	Level of Patient's Overall Patient Satisfaction to the Type of Closure	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)	Post-operative day 3 or 4
Secondary	Level of Patient's Overall Patient Satisfaction to the Type of Closure	Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)	Post-operative week 6