| CTRI Number |
CTRI/2024/12/077635 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
wound open vs closed with drain in patient after drainage of abscess |
|
Scientific Title of Study
|
Comparative study of conventional incision drainage versus incision drainage with primary closure and drain placement for treatment of acute abscesses |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishan Bhandari |
| Designation |
Junior Resident |
| Affiliation |
MGM medical college and hospital |
| Address |
Dept. of general surgery, MGM medical college and hospital
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9893129200 |
| Fax |
|
| Email |
vishan.bhandari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejinder Chhabda |
| Designation |
Professor |
| Affiliation |
MGM medical college and hospital, aurangabad |
| Address |
Dept. General srugery, MGM medical college and hospital, aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9850684545 |
| Fax |
|
| Email |
drtschhabda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishan Bhandari |
| Designation |
Junior Resident |
| Affiliation |
MGM medical college and hospital |
| Address |
Dept. of general surgery, Endoscopy(330), MGM medical college and hospital
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9893129200 |
| Fax |
|
| Email |
vishan.bhandari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of general surgery, mgm collega and hospital, aurangabad, maharashtra, india
pincode-431003 |
|
|
Primary Sponsor
|
| Name |
Dr Vishan Bhandari |
| Address |
Dept general surgery, Endoscopy 330, MGM medical college and hospital, aurangabad |
| Type of Sponsor |
Other [Indivdual] |
|
|
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 Vishan bhandari |
MGM medical college and hospital |
Department of general surgery,
Endoscopy 330
Aurangabad
MAHARASHTRA |
9893129200
vishan.bhandari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| mahatma gandhi missions ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Incision and drainage |
All the patients underwent incision at most prominent part of abscess, abscess evacuated sent for culture-sensitivity, abscess cavity cleaned with betadine and hydrogen peroxide followed by packing of cavity with sterile dressing |
| Intervention |
negative suction drain |
drain is placed inside the abscess cavity and cavity is closed with sutures, drain is later connected to sealed suction bottle. Drain is removed when collection in bottle is less than 5-10ml for 3 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients with acute superficial abscess willing to enroll |
|
| ExclusionCriteria |
| Details |
-Systemic disease like immunodeficiency, patient on steroid
-Intra-abdominal, pelvic, intra-thoracic, intra-cranial abscess |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare wound healing in patients without primary closure to patients with primary closure and drain insertion |
1st,3rd,5th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare post-operative pain
To compare duration of hospital stay
To compare recurrence rates |
6 months |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 3 |
|
Date of First Enrollment (India)
|
24/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is a comparison of wound healing in traditional incision drainage versus incision drainage with primary closure and drain placement for treating acute abscesses. |