| CTRI Number |
CTRI/2011/09/002002 [Registered on: 13/09/2011] Trial Registered Prospectively |
| Last Modified On: |
28/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Other (Specify) [ [Three types dressing the pressure ulcer] ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prevention and management of Bedsores |
|
Scientific Title of Study
|
Randomized controlled trial for community based Bedsore Prevention and Management. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukhpal Kaur |
| Designation |
Lecturer |
| Affiliation |
NINE,PGIMER |
| Address |
National Institute of Nursing Eduaction, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
01722744401 |
| Email |
sukhpal.trehan@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjeet singh |
| Designation |
Professor |
| Affiliation |
School of Public Health, PGIMER |
| Address |
Department of Community Medicine School of Public Health PGIMER Chandigarh India
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
01722744993 |
| Email |
amarminhas56@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarjeet singh |
| Designation |
|
| Affiliation |
|
| Address |
Department of Community Medicine School of Public Health PGIMER Chandigarh India
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
01722744993 |
| Email |
amarminhas56@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of medical research |
| Address |
ICMR, Ansari Nagar, PO Box No.4911, New Delhi- 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrSukhpal Kaur |
CHANDIGARH |
Room no.310,Department:National Institute Of Nursing Education, PGIMER, sector 12,Chandigarh.
Chandigarh
CHANDIGARH |
9888536964
01722744401
sukhpal.trehan@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Ulcer Prevention, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prevention package 1(PP1): Self instruction manual(SIM), training and counselling. |
Cases in stage 0 and 1(with no bedsores) will be included.Training includes positioning the patient, changing the posture of the patient, changing the bedsheet and clothes of the patient, feeding the patient, etc.Follow up:It will be weekly for one month, fortnightly for three months, monthly for six months and after every two months for one year.During follow up,one to one counselling and retraining will be done as per the need. |
| Comparator Agent |
Prevention package 2(PP2): Self Instruction Manual (SIM) |
Cases in stage 0 and 1(with no bedsores)will be included.Only SIM will be provided.Follow up:It will be weekly for one month, fortnightly for three months, monthly for six months and after every two months for one year.During follow up visits, no counselling will be given. |
| Intervention |
Treatment Package 1(TP1): Normal saline dressing to pressure ulcer with self instruction manual and counselling for further prevention and management of pressure ulcer |
Cases in stage 2 will be included.Dressing material:Normal saline. Frequency of dressing: once every 8 hours. Self instruction manual will be given along with one to one training and counselling. Follow up:It will be weekly for one month, fortnightly for three months, monthly for six months and after every two months for one year. |
| Comparator Agent |
Treatment package 2
( TP2):Neosporin ointment dressing to pressure ulcer with self instruction manual and counselling for further prevention and management of prssure ulcer. |
Cases in stage 2 will be included.Dressing material:Neosporin ointment. Frequency of dressing: once every 8 hours. Self instruction manual will be given along with one to one training and counselling. Follow up:It will be weekly for one month, fortnightly for three months, monthly for six months and after every two months for one year. |
| Comparator Agent |
Treatment package 3(TP3):Hydrocolloid dressing to pressure ulcer with self instruction manual and counselling for further prevention and management of pressure ulcer to patient and caregiver. |
Cases in stage 2 will be included.Dressing material:Hydrocolloid Frequency of dressing: once every 48-72 hours. Follow up : It will be weekly for one month, fortnightly for three months, monthly for six months and after every two months for one year. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the cases above 12years of age who had been confined to bed for more than 48 hours, for 90% of the time during the day and who are unable to get out of bed without assistance.The bedsore cases in stage 0, 1 and 2 shall be included in the study. |
|
| ExclusionCriteria |
| Details |
1.The cases with bedsores in stage 3 and 4 shall be excluded from the study. They will be explained that at this stage medical consultation is necessary.Referral advice will be given.This will not be included in the analysis.
2.All ambulatory cases i.e.those who could get out off the bed without assistance or those who could walk without assistance. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients developing bedsores along with grading and fate. |
22 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shifting of grade of bedsore from severe to mild category or complete resolution/ healing.
Grading of smell.
Subjective well being.
Changes in awareness level of family members regarding prevention and management of bedsores.
Skill gained by family members or caregivers.
Verbatim/ Subjective responses on level of satisfaction of family members.
During the follow up visits condition of the skin and bedsore will be noted and recorded on the performa. |
22 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2011 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Randomized controlled trial for community based bedsore prevention and management in bedridden patients will be carried out in chandigarh with a sample size of 30 patients each in five groups i.e prevention package 1, prevention package 2, treatment package 1, treatment package 2 and treatment package 3 with the following objectives:
1. To ascertain the long term care practices of the families of bedridden patients pertaining to bedsore management and prevention. 2.To compare the impact of two packages on the prevention of bedsores development in the bedridden patients. 3.To compare the impact of three packages on mangement of bedsores in the bedridden patients. |