MedDataX Logo

A Comparative Study of Incision Closure Methods for Total Knee Replacement

NCT ID: NCT01088074

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.

The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Replacement Closure Wound Closure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Total Knee Replacement Closure Methods

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Histoacryl Tissue Adhesive

Histoacryl Blue (HAB) Tissue Adhesive (n-butyl-2 cyanoacrylate; B. Braun Corp., Melsungen, Germany). Histocryl is a FDA-approved sterile liquid skin adhesive that has been utilized as a substitute for sutures for wound closure for approximately 40 years.

Group Type ACTIVE_COMPARATOR

Histoacryl Tissue Adhesive

Intervention Type DEVICE

Dermabond

Dermabond High Viscosity Tissue Adhesive (2-ocytl cyanoacrylate; Ethicon, Somerville, NJ). Dermabond is also a FDA-approved liquid bonding agent that has been utilized for wound closure for approximately 10 years and proven as effective as sutures.

Group Type ACTIVE_COMPARATOR

Dermabond

Intervention Type DEVICE

Staples

Visistat 35W Stapler (Teleflex Corp, Limerick, PA). The FDA-approved Weck staple system with stainless steel staples has been proven over years of use and remains the standard accepted closure approach due to speed of insertion as well as removal.

Group Type ACTIVE_COMPARATOR

Staples

Intervention Type DEVICE

Running Subcuticular with Monocryl

Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation.

Group Type ACTIVE_COMPARATOR

Monocryl 4-0

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Histoacryl Tissue Adhesive

Intervention Type DEVICE

Dermabond

Intervention Type DEVICE

Staples

Intervention Type DEVICE

Monocryl 4-0

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* TKA scheduled without a bilateral planned within one week of the initial surgery
* Willingness to attend prescribed physical therapy 3 times per week.

Exclusion Criteria

* Current participation in another clinical trial
* Preoperative systemic infections
* Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
* Known hypersensitivity to cyanoacrylate
* Formaldehyde, or the dye D\&C Violet #2
* Prior knee hardware fixation devices
* Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Foundation for Southwest Orthopedic Research

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foundation for Southwest Orthopedic Research

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB1108-0328

Identifier Type: -

Identifier Source: org_study_id