NCT01088074

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

March 16, 2010

Last Update Submit

August 21, 2012

Conditions

Total Knee Replacement ClosureWound Closure

Keywords

Total Knee ReplacementClosure Methods

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.

    1/2009-10/2009

Secondary Outcomes (1)

  • Mean postop hospital stay

    1/2009-10/2009

Study Arms (4)

Histoacryl Tissue Adhesive

ACTIVE COMPARATOR

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.

Device: Histoacryl Tissue Adhesive

Dermabond

ACTIVE COMPARATOR

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.

Device: Dermabond

Staples

ACTIVE COMPARATOR

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.

Device: Staples

Running Subcuticular with Monocryl

ACTIVE COMPARATOR

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

Device: Monocryl 4-0

Interventions

Histoacryl Tissue AdhesiveDEVICE
Histoacryl Tissue Adhesive
DermabondDEVICE
Dermabond
StaplesDEVICE
Staples
Monocryl 4-0DEVICE
Running Subcuticular with Monocryl

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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°.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation for Southwest Orthopedic Research

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

US(1)