| CTRI Number |
CTRI/2020/10/028668 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
09/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [hyperbaric oxygen therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
A prospective randomised control trial to evaluate the effect of adjunctive hyperbaric oxygen therapy in the clinical and microbiological outcome of infected pressure ulcers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haritha I |
| Designation |
Senior Resident |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department of Critical Care Medicine,
AIIMS,Rishikesh
E16 Mittal Bhavan, Ugrasennagar, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9447324451 |
| Fax |
|
| Email |
haritha.senan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Agarwal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department of Critical Care Medicine,
AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
|
| Fax |
|
| Email |
ankit.anaes@aiimsishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haritha I |
| Designation |
Senior Resident |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department of Critical Care Medicine,
AIIMS,Rishikesh
E16, Mittal Bhavan, Ugrasennagar, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9447324451 |
| Fax |
|
| Email |
haritha.senan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Haritha I |
| Address |
Senior Resident
Critical Care Medicine
AIIMS,Rishikesh |
| Type of Sponsor |
Other [the primary sponsor is the principal ivestigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haritha I |
AIIMS, RISHIKESH |
Department of Anesthesiology and Critical care medicine AIIMS RISHIKESH
Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203
Dehradun
UTTARANCHAL |
9447324451
haritha.senan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment for infected Pressure Sore(Group N) |
Group N will be given conventional treatment with
local antibacterial therapy with colloid silver, wound debridement , wound
dressing with normal saline and nutrition.
|
| Intervention |
Hyperbaric Oxygen therapy(Group H) |
The wounds of all selected patients based on well defined inclusion criterias will be clinically evaluated and documented which includes site, duration , Grading as per NPUAP staging system and initial PUSH score . In order to study the microbiology of the wound a wound swab is taken by rotating the tip of swab over 1 cm2 of the viable wound bed tissue for 5 seconds without touching the margins(Levine method) and
will be sent for culture and sensitivity and number of Colony forming units.(CFU)of microorganisms will be measured as per standard microbiological techniques. Group H will be given adjunctive hyperbaric oxygen therapy in addition to conventional therapy. Hyperbaric oxygen therapy is given at 2ATA for 60 minutes for 15 cycles.The wounds are clinically assessed for progress by calculating
the PUSH score and swab culture will be repeated at 5 th, 10 th and 15 th day after starting the treatment so as to assess the microbiological status of the wound by seeing the reduction in CFU of organisms in the
wound cycles. The wounds are clinically assessed for progression/healing by calculating the PUSH score and swab culture will be repeated at 5 th, 10 th and 15 th day after starting the treatment so as to assess the microbiological status of the wound by seeing the reduction in CFU of organisms in the
wound
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 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
|
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
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
|
| Outcome |
TimePoints |
To compare the mean duration of hospital stay in both groups.To assess the total number of patients requiring debridement in both groups
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be published after finishing study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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
|