Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies

July 30, 2017 updated by: dr mohammed elsafty, Ain Shams Maternity Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI more than 30kg/m2
  • midline laparotomies
  • ovarian cancer

Exclusion Criteria:

  • associated medical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group a
This arm will receive subcutaneous negative suction drain for the midline wound for 10 days.
Procedure: Subcutaneous negative suction drain for 10 days
ACTIVE_COMPARATOR: group b
This arm will receive closure of the midline wound without a subcutaneous drain.
Procedure: No subcutaneous drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of a break in the skin wound
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5374ASU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Wound Healing

Clinical Trials on Subcutaneous negative suction drain for 10 days

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe