Condition category
Digestive System
Date applied
25/01/2010
Date assigned
13/04/2010
Last edited
13/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ipek Ozyaylali

ORCID ID

Contact details

Cukurambar mahallesi
38.cd. 33/A
Ankara
06520
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Single dose intravenous antibiotic versus intravenous plus topical antibiotic prophylaxis in patients undergo elective unilateral inguinal hernia repair with polypropylene mesh.

Acronym

Study hypothesis

Generally antibiotic prophylaxis is not recommended for pure suture-tissue repairs for inguinal hernias on elective basis. However, prophylaxis may be useful when prosthetic materials as a foreign body are used. Single dose intravenous antibiotic prophylaxis may overcome the problem, but some centres are still experiencing high surgical site infection rates. Recently topical antibiotic use in addition to intravenous single shot have been examined.

Inguinal hernias consume a very big part of health resources. Surgical site infection, although not common, may increase that financial burden. Infection also is known to cause recurrence which is another element of further expenses.

Ethics approval

The institution where the study will be done is a private centre with no ethical authority. The antibiotics to be used in the study are registered with the Turkish Health Authority.

Study design

Single centre 2 arm interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet (in Turkish)

Condition

Inguinal hernia

Intervention

1. The routine prophylaxis group will receive single dose intravenous cephazolin.
2. The intervention group will also receive this shot. In addition, gentamycine will be used topically after the wound is irrigated with saline at the end of the repair before the subcutaneous tissue and the skin are closed.
Duration of follow up will be 30 days for postoperative infection rate and 1 year for late foreign body infection rate.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Surgical site infection
2. Superficial and deep infection rates
All outcomes will be measured at postoperative days: 1, 3, 7 and 30

Secondary outcome measures

1. Features of the infection
2. Treatment of the infection
3. Microbial culture and antibiogram
4. Financial portrait of the infection
All outcomes will be measured at postoperative days: 1, 3, 7 and 30

Overall trial start date

01/02/2010

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary unilateral inguinal hernia
2. Recurrent unilateral inguinal hernia
3. Elective repair
4. Male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 in total, in 2 arms

Participant exclusion criteria

Bilateral hernia repair


Recruitment start date

01/02/2010

Recruitment end date

01/11/2010

Locations

Countries of recruitment

Turkey

Trial participating centre

Cukurambar mahallesi, 38.cd. 33/A
Ankara
06520
Turkey

Sponsor information

Organisation

Ankara Hernia Centre (Turkey)

Sponsor details

Cukurambar mahallesi
38.cd. 33/A
Ankara
06520
Turkey

Sponsor type

Hospital/treatment centre

Website

http://www.herniaturk.org

Funders

Funder type

Hospital/treatment centre

Funder name

Ankara Hernia Centre (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes