Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement

Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01097135

Enrollment

600

Registered

2010-04-01

Start date

2010-03-31

Completion date

2012-12-31

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drainage

Brief summary

Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the length of hospital stay and the need for revision surgery or readmission. The aim of this research is to investigate the incidence of post-operative wound drainage following elective total joint arthroplasty using two surgical skin preparation protocols.

Interventions

DRUGDuraprep Surgical Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Subjects who are able and willing to provide informed consent 2. Male and non-pregnant, non-lactating, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old. 3. Subjects deemed able to comply with study visit schedule and procedures. 4. Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty.

Exclusion criteria

1. Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty. 2. Subjects undergoing non-elective total joint procedures. 3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception. 4. Subjects with known allergies or previous skin reaction to iodine povacrylex

Design outcomes

Primary

Measure	Time frame	Description
The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups	Up to one year following surgery	Starting on post operative day 1 (the first day following surgery), at the time of the surgical dressings are removed and changed, assessments will be made to determine level of post-operative wound drainage following TJA.

Secondary

Measure	Time frame
Length of hospital stay	until hospital discharge
Need for readmission or reoperation for up to 6 weeks following TJA	6 weeks post-op
The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.	until hospital discharge
Incidence of skin blistering.	up to one year post-op
Scar cosmesis at the first post-operative visit.	up to 6 weeks post-op
Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)	6 weeks post-op

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026