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 Modification(s)	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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Pradeep Kumar Singh  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 Contact Person Scientific Query Modification(s)	Name  Dr Pradeep Kumar Singh  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 Contact Person Public Query Modification(s)	Name  Dr Mahesh Kumar Sethi  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 Modification(s)	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 Modification(s)	No of Sites = 1   Contact Person  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   8789395345 surg_pradeep@aiimsbhubaneswar.edu.in
Details of Ethics Committee Modification(s)	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  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"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India) Modification(s)	15/10/2019
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="6" Days="1"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	NIL
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.