Does Preoperative Administration of Oral Doxycycline Decr... | NCT02688738

Studies
Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?

NCT02688738

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Feb 23, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Propionibacterium

Interventions

Doxycycline

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Feb 11, 2016

First Submission Date that Met QC Criteria

Feb 17, 2016

First Posted Date

Feb 23, 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

Feb 17, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.

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
Control	No Intervention	Standard of care
Treatment	Active Comparator	Oral doxycycline	Drug: Doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline	Drug		Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantification of P acnes grown from anaerobic or aerobic culture		within 14 days of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-All male patients (>18 years of age) undergoing shoulder arthroscopy

Exclusion Criteria:

Female patients
patients with active acne
patients who have taken antibiotics in the past month
doxycycline allergy
benzoyl peroxide allergy
clindamycin allergy
patients with psoriatic/eczematous or other lesions on the shoulder girdle.

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided