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CTRI Number  CTRI/2019/09/021388 [Registered on: 23/09/2019] Trial Registered Prospectively
Last Modified On: 27/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare number of infection between normal wounds dressing and wounds with machine dressing in open wounds after emergency operations of abdomen with pus: A comparison study 
Scientific Title of Study   Comparison of surgical site infection (SSI) between negative pressure wound therapy assisted delayed primary closure and conventional delayed primary closure in grossly contaminated emergency abdominal surgeries: A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Kumar Singh 
Designation  Assistant Professor 
Affiliation  institutional ethical committee, AIIMS Bhubaneswar 
Address  Department of General Surgery, Room No.-401, Academic block, AIIMS Bhubaneswar hospital

Khordha
ORISSA
751019
India 
Phone  8789395345  
Fax    
Email  surg_pradeep@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Kumar Singh 
Designation  Assistant Professor 
Affiliation  institutional ethical committee, AIIMS Bhubaneswar 
Address  Department of General Surgery, Room No.-401, Academic block, AIIMS Bhubaneswar hospital

Khordha
ORISSA
751019
India 
Phone  8789395345  
Fax    
Email  surg_pradeep@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Kumar Sethi 
Designation  Junior Resident 
Affiliation  institutional ethical committee, AIIMS Bhubaneswar 
Address  Department of General Surgery, PG 1A hostel, Room no. 105, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7008310085  
Fax    
Email  maheshsethi949@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar Hospital, Patrapada, Sijua Dist- Khurdha State- Odisha Pin-751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar Hospital 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Pradeep Kumar Singh  All India Institute Of Medical Sciences, Bhubaneswar  Department of General Surgery, Room No.-401, Academic block
Khordha
ORISSA 		 8789395345

surg_pradeep@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies) AIIMS BBSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional dressing  Patients undergoing grossly contaminated abdominal surgeries, sheath will be closed and abdomen wound (skin) will not be closed and conventional dressing will be done.Wound will be closed on post operative day 5 with delayed primary intention. 
Intervention  Negative pressure wound dressing  Patients undergoing grossly contaminated abdominal surgeries, sheath will be closed and abdomen wound (skin) will not be closed and will be assisted with negative pressure wound dressing. Wound will be closed on post operative day 5 with delayed primary intention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All abdominal emergency cases with features of peritonitis undergoing laparotomy with open mid-line incision.
All class-IV (dirty) wounds.
Laparoscopy surgeries converted to open surgeries
 
 
ExclusionCriteria 
Details  Pregnancy.
Laparoscopy surgeries.
Elective procedures.
Allergic to adhesive materials.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of Surgical site infection  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Rates of other surgical site complications i.e. hematoma, seroma, sheath dehiscence and burst abdomen.
Hospital length of stay. 		 30 days 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/10/2019 
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="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

SSI has a great burden over the patients and also over the healthcare system in terms of cost and hospital length of stay. Negative pressure wound therapy has a great impact on wound healing and also to decrease the SSI rates. This has been shown in previous studies in closed abdominal wounds. Previous studies have been done to assess the role of negative pressure wound dressing in decreasing the SSI in closed abdominal wounds and other type of wounds. But none of the study have been done to see the efficacy of negative pressure wound dressing in delayed primary closure wound in terms of decreasing the rate of SSI.

Our study includes all patients undergoing grossly contaminated emergency abdominal surgeries through mid-line incision. Post operative periods, skin will be will be closed with delayed primary intention in all patients and will be closed on post operative day 5. In one group, conventional wound dressing will be done. and in another group, negative pressure assisted wound dressing will be done. Primary outcome is to assess the rate of SSI within 30 days of surgery and secondary outcomes to assess the rates of other surgical site complications i.e. hematoma, seroma, sheath dehiscence and burst abdomen and the hospital length of stay.

 
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