Prophylaxis Of Wound Infections- Antibiotics in Renal Don... | NCT02089568

Studies
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

NCT02089568

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Completed

Last Update Posted

Aug 19, 2016Estimated

Enrollment

284Actual

Phase

Phase 4

Conditions

Infection

Interventions

Co-Amoxiclav
Normal Saline

Countries

United Kingdom

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

ID	Type	Description	Link
2012-000942-36	EudraCT Number

Status Module

Record Verification Date

Aug 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

Jul 2012

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 14, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 18, 2014Estimated

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

Aug 18, 2016

Last Update Posted Date

Aug 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nizam Mamode, Consultant Transplant Surgeon, Guy's and St Thomas' NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Guy's and St Thomas' NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Detailed Description

Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

284Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug: co-amoxiclav	Experimental	experimental	Drug: Co-Amoxiclav
Control	Placebo Comparator	comparator	Drug: Normal Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Co-Amoxiclav	Drug	Will receive 1.2g co-amoxiclav at induction	Drug: co-amoxiclav

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of infection after surgery		24 months

Secondary Outcomes

Measure	Description	Time Frame
Ultrasonic evidence of wound healing	Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.	24 months
Length of hospital stay		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
Women of child-bearing age taking adequate contraception will be included.

Exclusion Criteria:

Patients with a known allergy to penicillin or other antibiotics.
Patients with MRSA colonisation.
Participation in another investigational study within the previous 90 days.
Pregnant or breast-feeding women.

Accepts Healthy Volunteers

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nizam Mamode	Guy's and St Thomas' NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guy's and St Thomas' NHS Foundation Trust		London		SE1 9RT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019980	Amoxicillin-Potassium Clavulanate Combination
D000077330	Saline Solution

Ancestor Terms

ID	Term
D019818	Clavulanic Acid
D002969	Clavulanic Acids
D047090	beta-Lactams
D007769	Lactams

Browse Leaves

Not provided

Browse Branches

Not provided