Postoperative Wound HealingNCT02832076
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
A study testing Subcutaneous negative suction drain for 10 days and No subcutaneous drain in people with Postoperative Wound Healing, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Postoperative Wound Healing
- What is being tested?
- Subcutaneous negative suction drain for 10 days and No subcutaneous drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI more than 30kg/m2
- midline laparotomies
- ovarian cancer
Who cannot join
- associated medical disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Wound Healing
- Being tested
- Subcutaneous negative suction drain for 10 days, No subcutaneous drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous negative suction drain for 10 daysProcedure or surgery
No subcutaneous drainProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| group a | Experimental | This arm will receive subcutaneous negative suction drain for the midline wound for 10 days. Receives: 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. Receives: Procedure: No subcutaneous drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of a break in the skin wound
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohammed elsafty, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832076
- Sponsor's protocol ID
- 5374ASU
- Status last verified
- Jul 2017
- First submitted
- 8 Feb 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
- ClinicalTrials.gov ID
- NCT02832076
- Acronym / sponsor ID
- 5374ASU
- Conditions
- Postoperative Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group a | Experimental | Procedure: Subcutaneous negative suction drain for 10 daysThis arm will receive subcutaneous negative suction drain for the midline wound for 10 days. |
| group b | Active comparator | Procedure: No subcutaneous drainThis arm will receive closure of the midline wound without a subcutaneous drain. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI more than 30kg/m2
- midline laparotomies
- ovarian cancer
Key exclusion criteria (1 listed)
- associated medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous negative suction drain for 10 days | Procedure or surgery | group a |
| No subcutaneous drain | Procedure or surgery | group b |
Primary outcome
presence of a break in the skin wound
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous negative suction drain for 10 days and No subcutaneous drain in people with Postoperative Wound Healing, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of a break in the skin wound (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.