Bacterial Colonization With and Without Iodophor-impregna... | NCT02919410

Studies
Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

NCT02919410

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Sep 29, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Surgical Wound Infection

Interventions

iodophor-impregnated adhesive drapes
No adhesive drapes

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Sep 27, 2016

First Submission Date that Met QC Criteria

Sep 28, 2016

First Posted Date

Sep 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2016

Last Update Posted Date

Sep 29, 2016Estimated

Description Module

Brief Summary

This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery performed using iodophor-impregnated adhesive drapes	Active Comparator		Device: iodophor-impregnated adhesive drapes
Surgery performed without iodophor-impregnated adhesive drapes	Other		Other: No adhesive drapes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iodophor-impregnated adhesive drapes	Device		Surgery performed using iodophor-impregnated adhesive drapes
No adhesive drapes

Measure	Description	Time Frame
bacterial count from skin swabs		Immediately post-surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary femoroacetabular osteoplasty (FAO) patients
Primary Periacetabular Osteotomy (PAO) patients

Exclusion Criteria:

Total hip arthroplasty (THA) patients
Revision FAO surgery
Septic or septic arthritis patients
Patients with systemic or topical allergy to iodine

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided