Back to resultsRole of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
Primary Purpose
Postoperative Wound Healing
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Subcutaneous negative suction drain for 10 days
No subcutaneous drain
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Wound Healing
Eligibility Criteria
Inclusion Criteria:
- BMI more than 30kg/m2
- midline laparotomies
- ovarian cancer
Exclusion Criteria:
- associated medical disorders
Sites / Locations
- Ain Shams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group a
group b
Arm Description
This arm will receive subcutaneous negative suction drain for the midline wound for 10 days.
This arm will receive closure of the midline wound without a subcutaneous drain.
Outcomes
Primary Outcome Measures
presence of a break in the skin wound
Secondary Outcome Measures
Full Information
NCT ID
NCT02832076
First Posted
February 8, 2016
Last Updated
July 30, 2017
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02832076
Brief Title
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Healing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group a
Arm Type
Experimental
Arm Description
This arm will receive subcutaneous negative suction drain for the midline wound for 10 days.
Arm Title
group b
Arm Type
Active Comparator
Arm Description
This arm will receive closure of the midline wound without a subcutaneous drain.
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous negative suction drain for 10 days
Intervention Type
Procedure
Intervention Name(s)
No subcutaneous drain
Primary Outcome Measure Information:
Title
presence of a break in the skin wound
Time Frame
10 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI more than 30kg/m2
midline laparotomies
ovarian cancer
Exclusion Criteria:
associated medical disorders
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
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