Clinical trial NCT01097135: Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement
Official title: Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drainage
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2010-04-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to one year following surgery
Secondary outcomes:
measure: The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.
timeFrame: until hospital discharge
measure: Length of hospital stay
timeFrame: until hospital discharge
measure: Need for readmission or reoperation for up to 6 weeks following TJA
timeFrame: 6 weeks post-op
measure: Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)
timeFrame: 6 weeks post-op
measure: Incidence of skin blistering.
timeFrame: up to one year post-op
measure: Scar cosmesis at the first post-operative visit.
timeFrame: up to 6 weeks post-op
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Javad Parvizi, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: