Surgical Site InfectionPOSITIONNCT05179122
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION
A study testing Surgical drain in people with Surgical Site Infection and Gynecologic Cancer, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Gynecologic Cancer, Wound Drain
- What is being tested?
- Surgical drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to 15 Jan 2024
- 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 30 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer
Who cannot join
- Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.
Read the detailed description
Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.
Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.
- Conditions
- Surgical Site Infection, Gynecologic Cancer, Wound Drain
- Being tested
- Surgical drain
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical drainProcedure or surgery
In this arm a surgical drain will be inserted prior to surgical wound closure
| Study group | Role | What they receive |
|---|---|---|
| Surgical drain | Experimental | In this arm participants a surgical drain (Redon type) will be inserted above the abdominal fascia prior to suture of the subcutaneous tissue and of the skin Receives: Procedure: Surgical drain |
| Control | No intervention | In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of surgical site infection
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Measured: Within 30 days
Risk of surgical debridement of surgical site infection
Rates of surgical intervention to treat surgical site infection will be recorded
Measured: Within 30 days
Secondary outcomes (8)
Risk of wound dehiscence
Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded
Measured: Within 30 days
Length and depth of wound dehiscence
In case of wound dehiscence the length and depth will be measured in cm
Measured: Within 30 days
Risk of seroma formation
Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded.
Measured: Within 30 days
Risk and duration of fever related to surgical site infection
Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius
Measured: Within 30 days
Duration of antibiotic therapy directed against surgical site infection
The duration of post-operative use of antibiotics will be recorded in days
Measured: Within 30 days
Duration of hospitalization
Duration of hospitalization will be recorded in days
Measured: Within 30 days
Re-admission rates
Re-admission rates within 30 days will be reported
Measured: Within 30 days
Interval to adjuvant therapy
The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki, Saint Savvas Anticancer Hospital, Metaxa Hospital
- Responsible party
- Principal investigator, Dimitrios Haidopoulos, Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179122
- Sponsor's protocol ID
- 699/8-11-21
- Acronym
- POSITION
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahdi H, Gojayev A, Buechel M, Knight J, SanMarco J, Lockhart D, Michener C, Moslemi-Kebria M. Surgical site infection in women undergoing surgery for gynecologic cancer. Int J Gynecol Cancer. 2014 May;24(4):779-86. doi: 10.1097/IGC.0000000000000126.
PubMed 24681712Nugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15.
PubMed 21324517Manzoor B, Heywood N, Sharma A. Review of Subcutaneous Wound Drainage in Reducing Surgical Site Infections after Laparotomy. Surg Res Pract. 2015;2015:715803. doi: 10.1155/2015/715803. Epub 2015 Dec 13.
PubMed 26783556Pergialiotis V, Haidopoulos D, Tzortzis AS, Antonopoulos I, Thomakos N, Rodolakis A. The impact of waiting intervals on survival outcomes of patients with endometrial cancer: A systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004. Epub 2020 Jan 7.
PubMed 31923876Steiner HL, Strand EA. Surgical-site infection in gynecologic surgery: pathophysiology and prevention. Am J Obstet Gynecol. 2017 Aug;217(2):121-128. doi: 10.1016/j.ajog.2017.02.014. Epub 2017 Feb 14.
PubMed 28209490
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
- ClinicalTrials.gov ID
- NCT05179122
- Acronym / sponsor ID
- POSITION / 699/8-11-21
- Conditions
- Surgical Site Infection, Gynecologic Cancer, Wound Drain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki, Saint Savvas Anticancer Hospital, Metaxa Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 5 Jan 2022 (actual)
- 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 present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.
Detailed description
Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.
Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical drain | Experimental | Procedure: Surgical drainIn this arm participants a surgical drain (Redon type) will be inserted above the abdominal fascia prior to suture of the subcutaneous tissue and of the skin |
| Control | No intervention | –In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer
Key exclusion criteria (1 listed)
- Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases
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 |
|---|---|---|
| Surgical drainIn this arm a surgical drain will be inserted prior to surgical wound closure | Procedure or surgery | Surgical drain |
Primary outcome
Prevalence of surgical site infection
Time frame: Within 30 days
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Risk of surgical debridement of surgical site infection
Time frame: Within 30 days
Rates of surgical intervention to treat surgical site infection will be recorded
8 secondary outcomes
Risk of wound dehiscence
Time frame: Within 30 days
Length and depth of wound dehiscence
Time frame: Within 30 days
Risk of seroma formation
Time frame: Within 30 days
Risk and duration of fever related to surgical site infection
Time frame: Within 30 days
Duration of antibiotic therapy directed against surgical site infection
Time frame: Within 30 days
Duration of hospitalization
Time frame: Within 30 days
Re-admission rates
Time frame: Within 30 days
Interval to adjuvant therapy
Time frame: Within 30 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 2 Feb 2024.
- Background: PubMed 24681712Mahdi H, Gojayev A, Buechel M, Knight J, SanMarco J, Lockhart D, Michener C, Moslemi-Kebria M. Surgical site infection in women undergoing surgery for gynecologic cancer. Int J Gynecol Cancer. 2014 May;24(4):779-86. doi: 10.1097/IGC.0000000000000126.
- Background: PubMed 21324517Nugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15.
- Background: PubMed 26783556Manzoor B, Heywood N, Sharma A. Review of Subcutaneous Wound Drainage in Reducing Surgical Site Infections after Laparotomy. Surg Res Pract. 2015;2015:715803. doi: 10.1155/2015/715803. Epub 2015 Dec 13.
- Background: PubMed 31923876Pergialiotis V, Haidopoulos D, Tzortzis AS, Antonopoulos I, Thomakos N, Rodolakis A. The impact of waiting intervals on survival outcomes of patients with endometrial cancer: A systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004. Epub 2020 Jan 7.
- Results publication: PubMed 28209490Steiner HL, Strand EA. Surgical-site infection in gynecologic surgery: pathophysiology and prevention. Am J Obstet Gynecol. 2017 Aug;217(2):121-128. doi: 10.1016/j.ajog.2017.02.014. Epub 2017 Feb 14.
- Individual participant dataSharing planned: No
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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 Surgical drain in people with Surgical Site Infection and Gynecologic Cancer, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 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 2 Feb 2024. 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 Greece. 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?
Prevalence of surgical site infection (time frame: Within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179122, which also lists 5 linked publications.
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 2 Feb 2024.