NCT01687972

Brief Summary

The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
187

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

April 2, 2018

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

September 9, 2012

Results QC Date

March 9, 2017

Last Update Submit

August 29, 2017

Conditions

Cesarean SectionPregnancy

Keywords

cesarean sectioninsorb staplesabsorbable staplestransverse skin incision

Outcome Measures

Primary Outcomes (3)

  • Patient Pain Scale

    Visual Analog Score 0-10, with 0 being painless and 10 being the most severe

    3 months

  • Patient Scar Assessment Scale (PSAS)

    assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.

    6 weeks

  • Closure Time

    Number of minutes taken to close post cesarean section

    up to 20 minutes post intervention

Study Arms (2)

Sutures

ACTIVE COMPARATOR
Combination Product: Absorbable sutures

Insorb Staples

ACTIVE COMPARATOR
Combination Product: Insorb absorbable staples

Interventions

Insorb absorbable staplesCOMBINATION_PRODUCT

Placement of Insorb absorbable staples at cesarean section

Insorb Staples
Absorbable suturesCOMBINATION_PRODUCT

placement of absorbable sutures at cesarean section

Sutures

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • cesarean section via transverse skin incision informed consent

You may not qualify if:

  • vertical skin incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 20794, United States

Location

Related Publications (6)

  • Chelmow D, Rodriguez EJ, Sabatini MM. Suture closure of subcutaneous fat and wound disruption after cesarean delivery: a meta-analysis. Obstet Gynecol. 2004 May;103(5 Pt 1):974-80. doi: 10.1097/01.AOG.0000124807.76451.47.

    PMID: 15121573BACKGROUND

  • Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.

    PMID: 20816153BACKGROUND

  • Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.

    PMID: 20417924BACKGROUND

  • Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.

    PMID: 17825472BACKGROUND

  • Couto RC, Pedrosa TM, Nogueira JM, Gomes DL, Neto MF, Rezende NA. Post-discharge surveillance and infection rates in obstetric patients. Int J Gynaecol Obstet. 1998 Jun;61(3):227-31. doi: 10.1016/s0020-7292(98)00047-2.

    PMID: 9688482BACKGROUND

  • Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.

    PMID: 20334736BACKGROUND

Results Point of Contact

Title
Janice Henderson, MD Assistant Professor
Organization
Johns Hopkins Univesity School of Medicine
jhender7@jhmi.edu
443-287-2783

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 19, 2012

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 2, 2018

Results First Posted

April 2, 2018

Record last verified: 2017-08

Locations

US(1)