NCT01008449

Brief Summary

The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

September 3, 2014

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

November 4, 2009

Results QC Date

July 15, 2014

Last Update Submit

September 2, 2014

Conditions

Wound

Keywords

StaplesSuturesCesarean DeliveryWoundSkin ClosureWound infectionWound disruption

Outcome Measures

Primary Outcomes (1)

  • Percent of Subjects With Composite Wound Morbidity.

    this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed

    4-6 weeks post partum

Secondary Outcomes (7)

  • Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))

    at the end of follow up, 4 - 6 weeks post partum

  • Operative Procedure Time.

    Intraoperative, at time of intervention.

  • Post Operative Pain - 4 - 6 Weeks Post Delivery

    at end of follow-up, 4 - 6 weeks post partum

  • Post Operative Pain - 72 - 96 Hours Post Delivery

    72 - 96 hours post delivery

  • Subject Reported Satisfaction With Appearance of Scar

    4 - 6 weeks post delivery

  • +2 more secondary outcomes

Study Arms (2)

Absorbable Subcuticular Surgical Suture

ACTIVE COMPARATOR

Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.

Device: Absorbable Surgical Suture

Surgical staples

ACTIVE COMPARATOR

Patients in this arm will receive surgical staples for wound closure.

Device: Surgical staples

Interventions

Surgical staplesDEVICE

Surgical staples will be used once for wound closure.

Also known as: Proximate Plus MD 35 W, Ethicon Endo-surgery
Surgical staples
Absorbable Surgical SutureDEVICE

Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery.

Also known as: 4-0 Monocryl, Ethicon
Absorbable Subcuticular Surgical Suture

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cesarean delivery

You may not qualify if:

  • chronic use of immunosuppressive agents ( e.g.po steroids \> 2 weeks)
  • significant immune compromising disease (e.g. AIDS, CD4\<200)
  • contraindication to standard post operative pain management (acetaminophen, ibuprofen, oxycodone)
  • refusal or inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35249, United States

Location

Related Publications (4)

  • Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.

    PMID: 19254586BACKGROUND

  • Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

    PMID: 9350017BACKGROUND

  • Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.

    PMID: 12804476BACKGROUND

  • Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.

    PMID: 23262925DERIVED

Related Links

MeSH Terms

Conditions

Wounds and InjuriesWound Infection

Interventions

Sutures

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Results Point of Contact

Title
Principal Investigator
Organization
UAB
dana_figueroa_marzilli@hotmail.com
205-934-3411

Study Officials

  • Dana Figueroa, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Physician

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

September 3, 2014

Results First Posted

September 3, 2014

Record last verified: 2014-09

Locations

US(1)