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OpenTrials
Completed

NCT Number: NCT00940446

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

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.

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Key information

Conditions

Erythema Bruising Contusions Drainage Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana Orthopaedic Hospital

Indianapolis, Indiana, 46278, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insorb staples

Device

absorbable staples required for wound closure

Other names: Insorb absorbable stapler, GDW

metal staples (Ethicon metal stapler)

Device

wound closure with metal staples

Other names: Ethicon metal stapler

Primary outcomes

  1. Participants With Incisional Drainage, Swelling or Gaps of Incision

    Time frame: 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 outcomes

  1. Participants With Wound Complications - Hematoma

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orthopaedic Research Foundation

Other

Collaborators

  • OrthoIndy

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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