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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Erythema, Drainage, Bruising, Pain

Intervention / Treatment
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* Device: Insorb staples
* Device: metal staples (Ethicon metal stapler)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insorb staples<br>Subcuticular Absorbable staples | Device: Insorb staples<br>* absorbable staples required for wound closure<br>* Other names: GDW;|
| Active Comparator: Control<br>Metal staple wound closure | Device: metal staples (Ethicon metal stapler)<br>* wound closure with metal staples<br>* Other names: Ethicon metal stapler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Wound Complications - Hematoma | Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not. | up to 6 weeks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insorb staples, Metal Staples