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Irrigation and Suction Trial to Prevent SSI (I&S)

Primary Purpose

Surgical Site Infection, Diabete Mellitus, Abdominal Hysterectomy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Irrigation and suction through subcutaneus drains
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring suction,, Wound healing, pain, Hysterectomy

Eligibility Criteria

41 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Diabetic patients age above 40years BMI>25kg/m2 assigned to hysterectomy fit for anaesthesia patients with other medical disorders like hepatitis and hypertension will also be included in the study. Exclusion Criteria: a BMI of less than 25kg/m2 a preoperative haemoglobin level of less than 10 g/dl.

Sites / Locations

  • Lady Willingdon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

I&S arm

control

Arm Description

The 150 participants of the experimental arm will be assigned to the I&S group and they will be inserted bilateral Nelton drains of 24 sizes in the subcutaneous space after the closure of the rectus sheath. Their wound will be irrigated with 500cc Normal saline at running speed followed by suction for a full day. The procedure will be repeated for three consecutive days. The drains will be removed on the fourth postoperative day.

The 150 participants of the non-intervention group will be assigned to the control arm, The wound will be closed by interrupted mattress stitches without the insertion of subcutaneous drains.

Outcomes

Primary Outcome Measures

SSI rate
number(proportion)of surgical site infections in Intervention and control group

Secondary Outcome Measures

length of wound disruption
proportion of wound involved
Depth of wound disruption
involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome
pain score during hospital stay
composit mean pain score from 0-10, 10 will be maximum adverse outcome
pain score after discharge
composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12
Other complications
complications of wound in I&S group and control group
patient satisfaction
not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome

Full Information

First Posted
October 29, 2022
Last Updated
November 10, 2022
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05611944
Brief Title
Irrigation and Suction Trial to Prevent SSI
Acronym
I&S
Official Title
Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach. The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment. The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.
Detailed Description
This study will be carried out in Lady willingdon Hospital, Lahore. In this study, we will recruit middle-aged and elderly diabetic women who have been assigned to open abdominal hysterectomy due to different gynaecological reasons. This cohort is at great risk of surgical site infection and other risk factors of SSI like hypertension, hepatitis and malignancy may coexist in these women. The study period will span to include three hundred participants as calculated according to sample size. The women will be divided into either an I&S group or a control group by a simple random number container method. The women in the I&S group will be inserted with bilateral drains during surgery in subcutaneous tissue after the closure of the rectus sheath and irrigated with saline followed by suction through syringe suction attached to the wound for rest of the day. The procedure will continue for three days. On the fourth day, drains are removed and stitches are removed on the fourth postoperative day. In the control group, the wound will be closed by interrupted stitches without the insertion of subcutaneous drains. The dressing will be done daily for seven days. patients with no symptoms and signs of SS will be sent home on the eighth postoperative day. The patients will be followed for symptoms of SSI, pain, readmission rate, and other complications at 4,8 and 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Diabete Mellitus, Abdominal Hysterectomy
Keywords
suction,, Wound healing, pain, Hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomized by the random number container method into an equal number of I&S groups and control groups through the parallel assignment.
Masking
Outcomes Assessor
Masking Description
The groups will be masked to the Outcome assessor by assigning groups A and B instead of group names and the assessor will be kept blinded about which group is the I&S group.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I&S arm
Arm Type
Experimental
Arm Description
The 150 participants of the experimental arm will be assigned to the I&S group and they will be inserted bilateral Nelton drains of 24 sizes in the subcutaneous space after the closure of the rectus sheath. Their wound will be irrigated with 500cc Normal saline at running speed followed by suction for a full day. The procedure will be repeated for three consecutive days. The drains will be removed on the fourth postoperative day.
Arm Title
control
Arm Type
No Intervention
Arm Description
The 150 participants of the non-intervention group will be assigned to the control arm, The wound will be closed by interrupted mattress stitches without the insertion of subcutaneous drains.
Intervention Type
Device
Intervention Name(s)
Irrigation and suction through subcutaneus drains
Intervention Description
Irrigation of wound will done by attaching 500cc saline to the drain on one side and let it flow freely from the other drain followed by suction of wound by attaching 60cc suction syringes on both sides creating suction pressure for 100 cc fluid.
Primary Outcome Measure Information:
Title
SSI rate
Description
number(proportion)of surgical site infections in Intervention and control group
Time Frame
first postoperative day to eighth postoperative day
Secondary Outcome Measure Information:
Title
length of wound disruption
Description
proportion of wound involved
Time Frame
at the time of diagnosis
Title
Depth of wound disruption
Description
involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome
Time Frame
at the time of diagnosis
Title
pain score during hospital stay
Description
composit mean pain score from 0-10, 10 will be maximum adverse outcome
Time Frame
from first postoperative day to eightth postoperative day
Title
pain score after discharge
Description
composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12
Time Frame
from discharge to completion of 12 postoperative weeks
Title
Other complications
Description
complications of wound in I&S group and control group
Time Frame
from discharge to completion of 12 postoperative weeks
Title
patient satisfaction
Description
not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome
Time Frame
at12th postoperative weeks completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diabetic patients age above 40years BMI>25kg/m2 assigned to hysterectomy fit for anaesthesia patients with other medical disorders like hepatitis and hypertension will also be included in the study. Exclusion Criteria: a BMI of less than 25kg/m2 a preoperative haemoglobin level of less than 10 g/dl.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammmad Khalid, MBBS,MHM
Organizational Affiliation
Pakistan Institute of Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Lady Willingdon Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
042
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will be shared after publication of the study.
Citations:
PubMed Identifier
20459600
Citation
Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85.
Results Reference
background
PubMed Identifier
26140663
Citation
Hasan MY, Teo R, Nather A. Negative-pressure wound therapy for management of diabetic foot wounds: a review of the mechanism of action, clinical applications, and recent developments. Diabet Foot Ankle. 2015 Jul 1;6:27618. doi: 10.3402/dfa.v6.27618. eCollection 2015.
Results Reference
result
PubMed Identifier
31361302
Citation
Ivanzov S, Soynov I, Kulyabin Y, Zubritskiy A, Voitov A, Omelchenko A, Arkhipov A, Bogachev-Prokophiev A. Vacuum-assisted closure versus closed irrigation for deep sternal wound infection treatment in infants: a propensity score-matched study. Interact Cardiovasc Thorac Surg. 2019 Nov 1;29(5):776-782. doi: 10.1093/icvts/ivz167.
Results Reference
result

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Irrigation and Suction Trial to Prevent SSI

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