POWAR: Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02089568
• Collaborator: (none)
• Enrollment: 284
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Co-Amoxiclav; Drug: Normal Saline	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug: co-amoxiclav experimental	Drug: Co-Amoxiclav; Will receive 1.2g co-amoxiclav at induction; Other Names: Augmentin
Placebo Comparator: Control comparator	Drug: Normal Saline; Placebo - 0.9% saline

Outcome Measures

Primary Outcome Measures

1. Rate of infection after surgery [24 months]

Secondary Outcome Measures

1. Ultrasonic evidence of wound healing [24 months]

   Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.

2. Length of hospital stay [24 months]

3. Readmission rates [24 months]

4. Antibiotic associated side effects [24 months]

   Including diarrhoea and allergic reactions

5. Return to work and normal activities [24 months]

6. Quality of life [24 months]

7. Relative costs [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's and St Thomas' NHS Foundation Trust	London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• Guy's and St Thomas' NHS Foundation Trust

Investigators

• Principal Investigator: Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nizam Mamode, Consultant Transplant Surgeon, Guy's and St Thomas' NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02089568
• Other Study ID Numbers: POWAR; 2012-000942-36
• First Posted: Mar 18, 2014
• Last Update Posted: Aug 19, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Nizam Mamode, Consultant Transplant Surgeon, Guy's and St Thomas' NHS Foundation Trust: Living donation; Antibiotics; Laparoscopic surgery
• Additional relevant MeSH terms: Infections; Amoxicillin-Potassium Clavulanate Combination

Study Results

No Results Posted as of Aug 19, 2016