NCT01509950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2013

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

March 4, 2019

Completed
Last Updated

March 4, 2019

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

January 5, 2012

Results QC Date

November 1, 2018

Last Update Submit

November 1, 2018

Conditions

PregnancyCesarean Section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Level of Pain on a Scale at 6 Weeks Postpartum

    Post-operative week 6

  • Count of Participants With Wound Complications

    Post-operative week 6

  • Level of Patient Satisfaction to the Wound Appearance

    Post-operative day 3 or 4

  • Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum

    Post-operative week 6

  • Time From Skin Incision to the Skin Closure

    Day of cesarean delivery (up to 8 hours)

  • +5 more secondary outcomes

Study Arms (3)

Staples

ACTIVE COMPARATOR

Use of staples for skin closure at cesarean section

Procedure: Staples

Prolene non-absorbable sutures

ACTIVE COMPARATOR

Use of Prolene non-absorbable sutures for skin closure at cesarean section

Procedure: Prolene non-absorbable sutures

Absorbable sutures

ACTIVE COMPARATOR

Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.

Procedure: Absorbable Sutures

Interventions

StaplesPROCEDURE

Staples for closure of cesarean section skin incision

Also known as: Reflex one skin stapler 35 wide. Manufactured by Conmed
Staples
Prolene non-absorbable suturesPROCEDURE

Prolene non-absorbable sutures for closure of cesarean skin incision

Also known as: Prolene 2-0 18 inch on FS needle. Manufactured by Ethicon
Prolene non-absorbable sutures
Absorbable SuturesPROCEDURE

Absorbable sutures for closure of cesarean skin incision

Also known as: Monocryl or Vicryl. Manufactured by Ethicon
Absorbable sutures

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Childrens Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Suturesglycolide E-caprolactone copolymer

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Research Operations Manager
Organization
Stanford University
agirsen@stanford.edu
6507255720

Study Officials

  • Natali Aziz, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 13, 2012

Study Start

January 1, 2012

Primary Completion

May 4, 2013

Study Completion

May 4, 2013

Last Updated

March 4, 2019

Results First Posted

March 4, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)