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

Drainage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097135
• Other study ID #: RIFJPAR-10-02
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: September 16, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drainage

Intervention

Drug:
• Duraprep Surgical Solution

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to one year following surgery	No
Secondary	The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.		until hospital discharge	No
Secondary	Length of hospital stay		until hospital discharge	No
Secondary	Need for readmission or reoperation for up to 6 weeks following TJA		6 weeks post-op	No
Secondary	Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)		6 weeks post-op	No
Secondary	Incidence of skin blistering.		up to one year post-op	No
Secondary	Scar cosmesis at the first post-operative visit.		up to 6 weeks post-op	No