FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
Close