NCT02832076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

February 8, 2016

Last Update Submit

July 30, 2017

Conditions

Postoperative Wound Healing

Outcome Measures

Primary Outcomes (1)

  • presence of a break in the skin wound

    10 days

Study Arms (2)

group a

EXPERIMENTAL

This arm will receive subcutaneous negative suction drain for the midline wound for 10 days.

Procedure: Subcutaneous negative suction drain for 10 days

group b

ACTIVE COMPARATOR

This arm will receive closure of the midline wound without a subcutaneous drain.

Procedure: No subcutaneous drain

Interventions

Subcutaneous negative suction drain for 10 daysPROCEDURE
group a
No subcutaneous drainPROCEDURE
group b

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • associated medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2016

First Posted

July 14, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

EG(1)