NCT01446627

Brief Summary

The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

September 30, 2011

Last Update Submit

May 2, 2013

Conditions

Wound Infection

Keywords

Absorbable vicryl subcuticular staplesmetal stapleswound healingcesarean section

Outcome Measures

Primary Outcomes (1)

  • Wound infection/separation

    from time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Secondary Outcomes (2)

  • wound hematoma

    From time of surgery up until wound assessed to be completely healed, no longer than 1 year.

  • wound seroma

    From time of surgery up until wound assessed to be completely healed, no longer than 1 year.

Study Arms (2)

metal staples

Other: There is no intervention for this study

Insorb vicryl staples

Other: There is no intervention for this study

Interventions

There is no intervention for this studyOTHER

None, no intervention made.

Also known as: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.
Insorb vicryl staplesmetal staples

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing cesarean section who have their skin incision closed with staples.

You may qualify if:

  • Cesarean sections
  • UT patients

You may not qualify if:

  • Patients who have skin closed with suture, per attending choice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Jonathan P Faro, MD, PhD

    UTHSC at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, ObGyn

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 5, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(1)