NCT00940446

Brief Summary

The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

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

July 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2010

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

July 14, 2009

Results QC Date

April 3, 2017

Last Update Submit

January 4, 2018

Conditions

ErythemaDrainageBruisingPain

Keywords

Insorb staplesMetal Staples

Outcome Measures

Primary Outcomes (1)

  • Participants With Incisional Drainage, Swelling or Gaps of Incision

    Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.

    Discharge from initial hospital stay (2-5 days post-op)

Secondary Outcomes (1)

  • Participants With Wound Complications - Hematoma

    up to 6 weeks post-op

Study Arms (2)

Insorb staples

EXPERIMENTAL

Subcuticular Absorbable staples

Device: Insorb staples

Control

ACTIVE COMPARATOR

Metal staple wound closure

Device: metal staples (Ethicon metal stapler)

Interventions

Insorb staplesDEVICE

absorbable staples required for wound closure

Also known as: Insorb absorbable stapler, GDW
Insorb staples
metal staples (Ethicon metal stapler)DEVICE

wound closure with metal staples

Also known as: Ethicon metal stapler
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 years or older
  • Patient or legal representative is able to understand and provide signed consent for the procedure
  • Patient is willing and able to return for required follow-up visits
  • Patient needs a total hip arthroplasty surgical procedure

You may not qualify if:

  • Patient has an active infection
  • Patient is enrolled in another similar study
  • Patient has a known history of hepatitis
  • Patient has a known history of HIV
  • Patient has a known history of AIDs
  • Patient has a known history of IV drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Orthopaedic Hospital

Indianapolis, Indiana, 46278, United States

Location

MeSH Terms

Conditions

ErythemaContusionsPain

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds, NonpenetratingWounds and InjuriesNeurologic Manifestations

Results Point of Contact

Title
Dr David A Fisher
Organization
OrthoIndy
dafisher@orthoindy.com
(317) 802-2000

Study Officials

  • David A Fisher, MD

    Indiana Orthopaedic Hospital

    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
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 16, 2009

Study Start

July 1, 2007

Primary Completion

April 30, 2010

Study Completion

April 30, 2010

Last Updated

January 30, 2018

Results First Posted

January 30, 2018

Record last verified: 2018-01

Locations

US(1)