The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns

Completed

Conditions: Major burn injury
Injury, Occupational Diseases, Poisoning
Burn injury

Registration Number: ISRCTN16675260

Lead Sponsor: South Manchester University Hospitals NHS Trust (SMUHT) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

Adults (=16 years) with =15% total body surface area (TBSA) burn
Children (<16 years) with =10% TBSA burn

Exclusion Criteria

1. Patients sustaining injuries that behave fundamentally differently to thermal burns (chemical burns, electrical burns and non-burns (e.g. staphylococcal scalded skin syndrome etc.)
2. Major non-burn trauma in addition to a major burn injury
3. Patients whose presentation is delayed >12 hours post-injury
4. Severely immunocompromised
5. Post-transplant patients
6. Altered physiology (pregnant patients, children <1 year old)
7. Patients opting out of the study
8. Terminally ill, not receiving aggressive treatment
9. Patients who have recently participated or are participating in other clinical studies will be evaluated on a case by case basis to evaluate the risk to the patient, and any bias, which may be introduced to either study
10. Patients with gastrointestinal failure, requiring >24 consecutive hours of total parenteral nutrition

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Infection rates (pre-defined definitions)<br>2. Antibiotic requirements<br>3. Changes in the microbiological composition of faeces

Secondary Outcome Measures

Name	Time	Method
1. Mortality rate<br>2. Nutritional assessment<br>3. Insulin requirements<br>4. Assessment of gastrointestinal (GI) function<br>5. GI side effects<br>6. Fluid requirements<br>7. Haematologic and biochemical trends<br>8. Acute physiology scores<br>9. Healing times<br>10. Burn depth progression rates<br>11. Length of intensive care unit (ICU) and hospital stay<br>12. Mobilisation times<br>13. Activities of daily living independence times<br>14. Post-burns scarring assessment<br>15. Cost analysis