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A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00940446
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
OrthoIndy
Information provided by (Responsible Party):
Orthopaedic Research Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Erythema
Drainage
Bruising
Pain
Interventions Device: Insorb staples
Device: metal staples (Ethicon metal stapler)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insorb Staples Control
Hide Arm/Group Description

Subcuticular Absorbable staples

Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.

Metal staple wound closure

Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Insorb Staples Control Total
Hide Arm/Group Description Subcuticular Absorbable staples Metal staple wound closure Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
62.3
(45 to 82)
61.9
(41 to 82)
61.9
(41 to 82)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
15
  50.0%
20
  66.7%
35
  58.3%
Male
15
  50.0%
10
  33.3%
25
  41.7%
[1]
Measure Description: number and sex of study participants
Number of staples placed   [1] 
Measure Type: Number
Unit of measure:  Staples
Number Analyzed 30 participants 30 participants 60 participants
465 597 1062
[1]
Measure Description: we counted the number of staples used, collectively for all participants. This is a baseline number used for outcomes comparisons.
1.Primary Outcome
Title Participants With Incisional Drainage, Swelling or Gaps of Incision
Hide Description Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Time Frame Discharge from initial hospital stay (2-5 days post-op)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insorb Staples Control-metal Staples
Hide Arm/Group Description:

Subcuticular Absorbable staples

Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.

Metal staple wound closure

Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
10 16
2.Secondary Outcome
Title Participants With Wound Complications - Hematoma
Hide Description Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Time Frame up to 6 weeks post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insorb Staples Control
Hide Arm/Group Description:

Subcuticular Absorbable staples

30 enrollees

Avg age

Avg BMI

Sex

Avg # staples placed

Avg incision length

Metal staple wound closure

30 enrollees

Avg age

Avg BMI

Sex

Avg # staples placed

Avg incision length

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insorb Staples Control
Hide Arm/Group Description

Subcuticular Absorbable staples

Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.

Metal staple wound closure

Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.

All-Cause Mortality
Insorb Staples Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Insorb Staples Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insorb Staples Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr David A Fisher
Organization: OrthoIndy
Phone: (317) 802-2000
EMail: dafisher@orthoindy.com
Layout table for additonal information
Responsible Party: Orthopaedic Research Foundation
ClinicalTrials.gov Identifier: NCT00940446     History of Changes
Other Study ID Numbers: DAF_PC000001
First Submitted: July 14, 2009
First Posted: July 16, 2009
Results First Submitted: April 3, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018