A study to evaluate the effect of hyperbaric oxygen therapy along with local antibiotic therapy and wound care in the healing of infected pressure ulcers.

Phase 1

Not yet recruiting

• Conditions: Diseases of the skin and subcutaneous tissue,

• Registration Number: CTRI/2020/10/028668
• Lead Sponsor: Dr Haritha I

Brief Summary

This study is a randomised control trial to  compare the effect  of  hyperbaric oxygen therapy along with conventional therapy  over  conventional therapy alone   for the treatment of infected pressure ulcers. The study is conducted in AIIMS Rishikesh for a period of 18 months . The primary outcome is to compare clinical improvement in pressure sores which is assessed by PUSH score on day 5, 10 and 15 after starting treatment. Microbiological improvement is also compared by serially assessing the colony forming units of organism isolated fom the wound  culture on day 5, 10 and 15 . The secondary outcome is to compare the mean duration of hospital stay in both groups and to assess the total number of patients requiring debridement in both groups

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-11
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients above the age >18 years and <60 years 2.
• Patients with infected pressure ulcers as evidenced by positive gram stain/ wound cultures 3.
• Who give consent to take part in the study.

Exclusion Criteria

• Exclusion Criteria : 1.
• Patients who do not give consent 2.
• Age < 18 years > 60years 3.Patients with pneumothorax, COPD 4.Patients with ejection fraction less than 35 % 5.Pregnant patients, Post chemotherapy patients.
• 8 .Patients with ear disease seizure disorders, hereditary Spherocytosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the clinical effect of hyperbaric oxygen therapy on pressure ulcers by serially assessing change in PUSH score ( Pressure Ulcer Scale for Healing) of the wound. To compare the microbiological effect of hyperbaric oxygen therapy on	15 days
pressure ulcers by serially evaluating the change in colony forming units of microorganisms isolated from the wound culture as per standard microbiological techniques	15 days

Secondary Outcome Measures

Name	Time	Method
To compare the mean duration of hospital stay in both groups.To assess the total number of patients requiring debridement in both groups

Trial Locations

Locations (1)

AIIMS, RISHIKESH; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS, RISHIKESH

🇮🇳Dehradun, UTTARANCHAL, India

Dr Haritha I

Principal investigator

9447324451

haritha.senan@gmail.com