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

• Sponsor: Orthopaedic Research Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00940446
• Collaborator: OrthoIndy (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erythema; Drainage; Bruising; Pain	Device: Insorb staples; Device: metal staples (Ethicon metal stapler)	N/A

Detailed Description

Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Apr 30, 2010
• Actual Study Completion Date: Apr 30, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insorb staples Subcuticular Absorbable staples	Device: Insorb staples; absorbable staples required for wound closure; Other Names: Insorb absorbable stapler GDW
Active Comparator: Control Metal staple wound closure	Device: metal staples (Ethicon metal stapler); wound closure with metal staples; Other Names: Ethicon metal stapler

Outcome Measures

Primary Outcome Measures

1. Participants With Incisional Drainage, Swelling or Gaps of Incision [Discharge from initial hospital stay (2-5 days post-op)]

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

Secondary Outcome Measures

1. Participants With Wound Complications - Hematoma [up to 6 weeks post-op]

   Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana Orthopaedic Hospital	Indianapolis	Indiana	United States	46278

Sponsors and Collaborators

• Orthopaedic Research Foundation
• OrthoIndy

Investigators

• Principal Investigator: David A Fisher, MD, Indiana Orthopaedic Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orthopaedic Research Foundation
• ClinicalTrials.gov Identifier: NCT00940446
• Other Study ID Numbers: DAF_PC000001
• First Posted: Jul 16, 2009
• Last Update Posted: Jan 30, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Orthopaedic Research Foundation: Insorb staples; Metal Staples
• Additional relevant MeSH terms: Erythema

Study Results

Participant Flow

Arm/Group Title	Insorb Staples	Control
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

Baseline Characteristics

Arm/Group Title	Insorb Staples	Control	Total
Arm/Group Description	Subcuticular Absorbable staples	Metal staple wound closure	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62.3	61.9	61.9
Sex: Female, Male (Count of Participants)
Female	15 50%	20 66.7%	35 58.3%
Male	15 50%	10 33.3%	25 41.7%
Number of staples placed (staples) [Number]
Number [staples]	465	597	1062

Outcome Measures

1. Primary Outcome

Title	Participants With Incisional Drainage, Swelling or Gaps of Incision
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insorb Staples	Control-metal Staples
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.
Measure Participants	30	30
Number [participants]	10 33.3%	16 53.3%

2. Secondary Outcome

Title	Participants With Wound Complications - Hematoma
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insorb Staples	Control
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
Measure Participants	30	30
Number [participants]	0 0%	1 3.3%

Adverse Events

Arm/Group Title	Insorb Staples		Control
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Insorb Staples		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Insorb Staples		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.