| CTRI Number |
CTRI/2024/03/064150 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing wound outcome in corrugated rubber drain vs romovac drain in patients undergoing exploratory laparotomy |
|
Scientific Title of Study
|
Comparison of Wound Outcome in Subcutaneous Negative Suction Drain V/S Subcutaneous Corrugated Rubber Drain in Closure Of Midline Incision in Patients Undergoing Emergency Laparotomy for Perforation Peritonitis |
| 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 Mona Aggarwal |
| Designation |
Post graduate junior resident |
| Affiliation |
All India Institute of Medical sciences, Raipur |
| Address |
Office of general surgery, D Block, All India Institute of Medical sciences, Raipur Tatibandh, Raipur
Chhatisgarh
India
492099
Raipur CHHATTISGARH 492099 India |
| Phone |
8630587214 |
| Fax |
|
| Email |
Maniaaggarwal079@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Radhakrishna Ramchandani |
| Designation |
Asoociate Professor |
| Affiliation |
All India Institute of Medical sciences, Raipur |
| Address |
Room No. 8, ground floor, A Block, All India Institute of Medical sciences, Raipur Tatibandh, Raipur
Chhatisgarh
India
492099
Raipur CHHATTISGARH 492099 India |
| Phone |
942204224 |
| Fax |
|
| Email |
drrramchandani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Radhakrishna Ramchandani |
| Designation |
Asoociate Professor |
| Affiliation |
All India Institute of Medical sciences, Raipur |
| Address |
ROOM NO. 8, GROUND FLOOR, A BLOCK, DEPARTMENT OF GENERAL SURGERY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES,TATIBANDH, RAIPUR
CHHATISGARH
492099
INDIA
Raipur CHHATTISGARH 492099 India |
| Phone |
942204224 |
| Fax |
|
| Email |
drrramchandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences Raipur |
| Address |
Ofiice of genral surgery, D block, 4th floor, All India Institute of Medical sciences, Raipur Tatibandh, Raipur
Chhatisgarh
India
492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mona aggrawal |
All India Institute of Medical sciences, Raipur |
2a2 ward, 2nd floor, A block
Raipur CHHATTISGARH |
8630587214
Maniaaggarwal079@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, Aiims Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K650||Generalized (acute) peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of Wound Outcome in Subcutaneous Corrugated Rubber Drain in Closure Of Midline Incision in Patients Undergoing Emergency Laparotomy for Perforation Peritonitis |
Subcutaneous corrugated rubber drain will be placed in subcutaneous space and drain to be kept till no soakage of gauze piece and patient to be followed up till 1 month after surgery for any local wound complications. |
| Intervention |
Comparison of Wound Outcome in Subcutaneous Negative Suction Drain in Closure Of Midline Incision in Patients Undergoing Emergency Laparotomy for Perforation Peritonitis |
Subcutaneous Negative Suction Drain will be placed in subcutaneous space and drain to be kept in situ till drain output becomes less than 5ml and patient to be followed till 1 month after surgery for any local wound complications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Perforation peritonitis
>18 years of age
Consent given |
|
| ExclusionCriteria |
| Details |
Midline laparotomy for other conditions, less than 18 years of age, Previous history of laparotomy, Patients with laparostomy, Undergoing re-exploration with in 15
days of surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Seroma formation, Hematoma and superficial wound dehiscence and need for intervention in both the study groups. |
4 weeks after operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Duration of antibiotic use & hospital stay
|
4 weeks after operative day |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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 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
|
Perforation
peritonitis is one of the commonest emergencies encountered by the
surgeons.It is associated with highest rate of infective complication
specially surgical site infection because there is contamination of
Operative field with micro organism from endogenous source. The
existing practice of closure of midline laparotomy wound is that
after closing the rectus sheath either subcutaneous tissue is closed
with absorbable sutures followed by skin closure with non-absorbable
suture or the skin is closed with non absorbable sutures after
closing the rectus sheath directly. Here,
In this study, a drain (negative suction drain or corrugated drain)
in the subcutaneous plane will be placed and then skin to be closed. Many
times it has been seen that blood or fluid get collected in the
subcutaneous space and this either just oozes out from the midline
wound or stays in the plane for a long time. It is apprehended that
this collected fluid or blood could be a nidus for the growth of
organisms leading to surgical site infections. Applying drain will be
helpful for removal of this collection and can potentially reduce the
risk of SSI.
The
selection of an appropriate drain type is crucial for achieving
optimal wound healing outcomes. Negative suction drains are designed
to actively remove fluids from the wound site using a vacuum system,
while corrugated rubber drains passively collect fluids through
capillary action.
It
is anticipated that this study will provide valuable insights into
the comparative effectiveness of negative suction drain versus
corrugated rubber drain in subcutaneous space in preventing surgical
site infection. The results may influence in selecting the most
appropriate drain type based on wound healing outcomes, patient
comfort, and satisfaction. Ultimately, this research aims to optimize
postoperative care and enhance patient outcomes in surgical
procedures requiring subcutaneous drainage.
Previous
studies have been done to compare the wound outcome in preventing SSI
between negative suction drain and no drain in which negative drain
is superior but very few studies are there which compares 2 different
types of drainage system in managing midline wounds.
This
thesis proposal aims to compare the wound outcome between the use of
negative suction and corrugated rubber drain in subcutaneous negative
pressure drainage. The choice of drain type may significantly impact
wound healing, but limited research exists on the direct comparison
of negative suction and corrugated rubber drains in the subcutaneous
plane. This study seeks to bridge this knowledge gap by evaluating
wound outcomes associated with these two drainage techniques.
Therefore,
a comparative analysis between ‘negative suction drain’ vs
‘corrugated rubber drain’ in the subcutaneous plane for
postoperative stay and other postoperative complications is essential
for the wound outcome.
|