Wound InfectionGO-VACNCT04584957
Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)
A study testing VAC therapy in people with Wound Infection and Gynecologic Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Wound Infection, Gynecologic Cancer
- What is being tested?
- VAC therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2020to 18 Sep 2021
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with:
- Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in:
- Ovarian cancer: primary debulking surgery (PDS) or interval debulking surgery (IDS) (minimum total hysterectomy+bilateral salpingo-oophorectomy+lymphadenectomy in early ovarian cancer [EOC] should be done to include the patient in the trial) or secondary debulking surgery at recurrence (SCS).
- Endometrial cancer FIGO stage IV or staging surgery for high risk endometrial cancer
- Uterine Sarcomas FIGO stage IIB-IV
- Previous history of pelvic or abdominal radiotherapy (even locally advanced cervical cancer [LACC] post neoadjuvant (NAD) therapies [NAD chemo-radiation or chemotherapy alone])
Show all 10Show fewer
- Persistent or recurrent Cervical cancer
- Obesity (>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies
- Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies
- Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies.
Who cannot join
- uncontrolled diabetes mellitus
- severe cardiac dysfunction
- pregnancy
- underweight (body mass index [BMI] < 18.5 kg/sqm)
- long-term steroid use
- subcutaneous (e.g. Jackson Pratt) drainage positioning
Show all 9Show fewer
- post-operative prophylactic use of antibiotics beyond the intraoperative short therapy
- contaminated (class III) and dirty/infected (class IV) incision [10]
- allergy to silver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)
A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery.
Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.
Read the detailed description
Wound complications in patients undergoing surgery for malignancies have a negative impact on quality of life and, in addition, are associated with an increase of the duration of hospital stay, imparting a significant socio-economic burden.
Several approaches have been proposed to reduce the wound complications rate without success. Instead, a novel and promising method has been employed which utilizes prophylactic negative pressure wound therapy placed over clean and closed surgical incisions immediately after surgery (ciNPWT).
In a recent meta-analysis across studies including all types of wounds and surgeries, ciNPWT was observed to reduce by 29.4 % the incidence of SSI and the odds of SSI. In the same meta-analysis, while limiting attention to general abdominal surgery alone, the weighted average of the selected studies reported a reduction in wound complications of 10.43% (13.54% vs 23.97%) for the ciNPWT group compared with controls which was a significant benefit.
This study is a prospective multi-centre controlled randomized trial, where after gynecologic oncologic laparotomic surgery and standard abdominal wall closure (if inclusion criteria result satisfied), patient is randomized to one of the two arms of the study: ARM A (sperimental): ciNPWT ARM B ( control): standard dressing.
For women in arm A: prophylactic ciNPWT therapy entails placement of the device over a closed incision immediately post-operatively. The device may be left in place with no additional intervention for up to 7 days. The use of the device does not require specialty care services or continued hospitalization. For women in arm B: standard dressing should be changed every 2 days after sterile medication.
People will be visited after 7 day of VAC-therapy (first visit) , discharge time (second visit or coincidence with the first visit), after 15 days from surgery (third visit for agraphis removal), after 30 days from surgery (fourth visit).
Sample size determination. A review of previous literature suggests that the incidence of wound-SSI is about 35% in G.O. patients. We assume that the use of ciNPWT could be linked to an wound-SSI incidence of 15% Setting a two-sided α=0.05 and power = 80%, the sample size is N=164 subjects. A dropout rate of 20% is added, reaching a final sample size of N=196 subjects (98 subjects per arm).
The primary objective will be achieved calculating and comparing the proportions of wound-SSI in the two arms. The comparison will be performed with a Chi-squared test. The same test will be applied to the comparisons of final and intermediate wound healing rates. The comparison of the proportion of wound complications and the proportion of patients in need of antibiotics will be achieved with a Chi-squared test, as well. Comparison of the time of operating room required to apply the dressings, hospital stay and time to adjuvant therapies will be performed with a T-test (if data are normally distributed) or with the Wilcoxon test (if data are not normal). A p-value <0.05 will be considered statistically significant.
All patient data will be collected and managed using an electronic database anonymously.
- Conditions
- Wound Infection, Gynecologic Cancer
- Being tested
- VAC therapy
- Keywords
- Gynecologic oncologic laparotomic surgery, Prophylactic negative pressure wound therapy, Surgical site infection, Wound dehiscence
- Medical subject headings
- Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC therapyDevice
Prophylactic ciNPWT therapy (Prevena® KCI) entails placement of the device over a closed incision immediately post-operatively. Prevena® KCI may be left in place with no additional intervention for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| VAC therapy | Active comparator | Prophylactic ciNPWT therapy positioning YES. Patients enrolled for placement of the device over a closed incision immediately post-operatively. Receives: Device: VAC therapy |
| Standard Closure | No intervention | Prophylactic ciNPWT therapy positioning NO. Patients enrolled for standard laparotomic closure without ciNPWT positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the rate of surgical site infections at 15 days
To investigate whether the application of an ciNPWT device (Prevena Incision Management System, KCI, Inc., San Antonio, TX, USA) change the rate of surgical site infections (SSI) within 15 postoperative days in gynecologic oncology patients undergoing surgery, from 35 % to 15 %.
Measured: 15 days
Secondary outcomes (6)
Wound complications at 30 days
Evaluate, compare and describe wound complications through the systematic performing of surgical wound swab at 7, 15, 30 days after surgery
Measured: 30 days
Change of the rate of surgical site infections at 7 days
Evaluate and compare the wound healing rate at intermediate evaluation
Measured: 7 days
Estimated operative time
Evaluate and compare the time required for use of the operating room
Measured: 1 day
Estimated hospital stay
Evaluate and compare the duration of hospital stay
Measured: 3-30 days
Antibiotic therapy estimate
Evaluate and compare the proportions of patients requiring antibiotics because of wound complications
Measured: 30 days
Time to start adjuvant therapy
Evaluate and compare the time to eventual adjuvant therapies.
Measured: 30-50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start18 Sep 2020
- Primary completion18 Sep 2021 (estimated)
- Study completion18 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After gynecologic oncologic laparotomic surgery and standard abdominal wall closure patients are randomized to one of the two arms of the study: sperimental arm (ciNPWT- closed incisional negative pressure wound therapy) and control arm (standard dressing)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
- Investigators
- Giovanni Scambia, Professor, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, IRCCS,Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584957
- Sponsor's protocol ID
- G.O-VAC. ID. 3316
- Acronym
- GO-VAC
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
PubMed 12603990Wechter ME, Pearlman MD, Hartmann KE. Reclosure of the disrupted laparotomy wound: a systematic review. Obstet Gynecol. 2005 Aug;106(2):376-83. doi: 10.1097/01.AOG.0000171114.75338.06.
PubMed 16055590Nugent 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 21324517Kim SI, Lim MC, Song YJ, Seo SS, Kang S, Park SY. Application of a subcutaneous negative pressure drain without subcutaneous suture: impact on wound healing in gynecologic surgery. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:94-100. doi: 10.1016/j.ejogrb.2013.12.006. Epub 2013 Dec 15.
PubMed 24388401Kim SI, Lim MC, Bae HS, Shin SR, Seo SS, Kang S, Park SY. Benefit of negative pressure drain within surgical wound after cytoreductive surgery for ovarian cancer. Int J Gynecol Cancer. 2015 Jan;25(1):145-51. doi: 10.1097/IGC.0000000000000315.
PubMed 25386858Scalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, Gesuita R, Di Benedetto G. Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2016 Dec;13(6):1260-1281. doi: 10.1111/iwj.12492. Epub 2015 Oct 1.
PubMed 26424609Willy C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12.
PubMed 27170231Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.
PubMed 26313829Blackham AU, Farrah JP, McCoy TP, Schmidt BS, Shen P. Prevention of surgical site infections in high-risk patients with laparotomy incisions using negative-pressure therapy. Am J Surg. 2013 Jun;205(6):647-54. doi: 10.1016/j.amjsurg.2012.06.007. Epub 2013 Jan 30.
PubMed 23375758Lynam S, Mark KS, Temkin SM. Primary Placement of Incisional Negative Pressure Wound Therapy at Time of Laparotomy for Gynecologic Malignancies. Int J Gynecol Cancer. 2016 Oct;26(8):1525-9. doi: 10.1097/IGC.0000000000000792.
PubMed 27488215Mahdi 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 24681712
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)
- ClinicalTrials.gov ID
- NCT04584957
- Acronym / sponsor ID
- GO-VAC / G.O-VAC. ID. 3316
- Conditions
- Wound Infection, Gynecologic Cancer
- Keywords
- Gynecologic oncologic laparotomic surgery, Prophylactic negative pressure wound therapy, Surgical site infection, Wound dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 18 Sep 2021 (estimated)
- Study completion
- 18 Sep 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery.
Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.
Detailed description
Wound complications in patients undergoing surgery for malignancies have a negative impact on quality of life and, in addition, are associated with an increase of the duration of hospital stay, imparting a significant socio-economic burden.
Several approaches have been proposed to reduce the wound complications rate without success. Instead, a novel and promising method has been employed which utilizes prophylactic negative pressure wound therapy placed over clean and closed surgical incisions immediately after surgery (ciNPWT).
In a recent meta-analysis across studies including all types of wounds and surgeries, ciNPWT was observed to reduce by 29.4 % the incidence of SSI and the odds of SSI. In the same meta-analysis, while limiting attention to general abdominal surgery alone, the weighted average of the selected studies reported a reduction in wound complications of 10.43% (13.54% vs 23.97%) for the ciNPWT group compared with controls which was a significant benefit.
This study is a prospective multi-centre controlled randomized trial, where after gynecologic oncologic laparotomic surgery and standard abdominal wall closure (if inclusion criteria result satisfied), patient is randomized to one of the two arms of the study: ARM A (sperimental): ciNPWT ARM B ( control): standard dressing.
For women in arm A: prophylactic ciNPWT therapy entails placement of the device over a closed incision immediately post-operatively. The device may be left in place with no additional intervention for up to 7 days. The use of the device does not require specialty care services or continued hospitalization. For women in arm B: standard dressing should be changed every 2 days after sterile medication.
People will be visited after 7 day of VAC-therapy (first visit) , discharge time (second visit or coincidence with the first visit), after 15 days from surgery (third visit for agraphis removal), after 30 days from surgery (fourth visit).
Sample size determination. A review of previous literature suggests that the incidence of wound-SSI is about 35% in G.O. patients. We assume that the use of ciNPWT could be linked to an wound-SSI incidence of 15% Setting a two-sided α=0.05 and power = 80%, the sample size is N=164 subjects. A dropout rate of 20% is added, reaching a final sample size of N=196 subjects (98 subjects per arm).
The primary objective will be achieved calculating and comparing the proportions of wound-SSI in the two arms. The comparison will be performed with a Chi-squared test. The same test will be applied to the comparisons of final and intermediate wound healing rates. The comparison of the proportion of wound complications and the proportion of patients in need of antibiotics will be achieved with a Chi-squared test, as well. Comparison of the time of operating room required to apply the dressings, hospital stay and time to adjuvant therapies will be performed with a T-test (if data are normally distributed) or with the Wilcoxon test (if data are not normal). A p-value <0.05 will be considered statistically significant.
All patient data will be collected and managed using an electronic database anonymously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- After gynecologic oncologic laparotomic surgery and standard abdominal wall closure patients are randomized to one of the two arms of the study: sperimental arm (ciNPWT- closed incisional negative pressure wound therapy) and control arm (standard dressing)
| Arm | Type | Receives |
|---|---|---|
| VAC therapy | Active comparator | Device: VAC therapyProphylactic ciNPWT therapy positioning YES. Patients enrolled for placement of the device over a closed incision immediately post-operatively. |
| Standard Closure | No intervention | –Prophylactic ciNPWT therapy positioning NO. Patients enrolled for standard laparotomic closure without ciNPWT positioning |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with:
- Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in:
- Obesity (>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies
- Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies
- Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies.
Key exclusion criteria (9 listed)
- uncontrolled diabetes mellitus
- severe cardiac dysfunction
- pregnancy
- underweight (body mass index [BMI] < 18.5 kg/sqm)
- long-term steroid use
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 |
|---|---|---|
| VAC therapyProphylactic ciNPWT therapy (Prevena® KCI) entails placement of the device over a closed incision immediately post-operatively. Prevena® KCI may be left in place with no additional intervention for up to 7 days. | Device | VAC therapy |
Primary outcome
Change of the rate of surgical site infections at 15 days
Time frame: 15 days
To investigate whether the application of an ciNPWT device (Prevena Incision Management System, KCI, Inc., San Antonio, TX, USA) change the rate of surgical site infections (SSI) within 15 postoperative days in gynecologic oncology patients undergoing surgery, from 35 % to 15 %.
6 secondary outcomes
Wound complications at 30 days
Time frame: 30 days
Change of the rate of surgical site infections at 7 days
Time frame: 7 days
Estimated operative time
Time frame: 1 day
Estimated hospital stay
Time frame: 3-30 days
Antibiotic therapy estimate
Time frame: 30 days
Time to start adjuvant therapy
Time frame: 30-50 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 12603990Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
- Background: PubMed 16055590Wechter ME, Pearlman MD, Hartmann KE. Reclosure of the disrupted laparotomy wound: a systematic review. Obstet Gynecol. 2005 Aug;106(2):376-83. doi: 10.1097/01.AOG.0000171114.75338.06.
- 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 24388401Kim SI, Lim MC, Song YJ, Seo SS, Kang S, Park SY. Application of a subcutaneous negative pressure drain without subcutaneous suture: impact on wound healing in gynecologic surgery. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:94-100. doi: 10.1016/j.ejogrb.2013.12.006. Epub 2013 Dec 15.
- Background: PubMed 25386858Kim SI, Lim MC, Bae HS, Shin SR, Seo SS, Kang S, Park SY. Benefit of negative pressure drain within surgical wound after cytoreductive surgery for ovarian cancer. Int J Gynecol Cancer. 2015 Jan;25(1):145-51. doi: 10.1097/IGC.0000000000000315.
- Background: PubMed 26424609Scalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, Gesuita R, Di Benedetto G. Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2016 Dec;13(6):1260-1281. doi: 10.1111/iwj.12492. Epub 2015 Oct 1.
- Background: PubMed 27170231Willy C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12.
- Background: PubMed 26313829Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.
- Background: PubMed 23375758Blackham AU, Farrah JP, McCoy TP, Schmidt BS, Shen P. Prevention of surgical site infections in high-risk patients with laparotomy incisions using negative-pressure therapy. Am J Surg. 2013 Jun;205(6):647-54. doi: 10.1016/j.amjsurg.2012.06.007. Epub 2013 Jan 30.
- Background: PubMed 27488215Lynam S, Mark KS, Temkin SM. Primary Placement of Incisional Negative Pressure Wound Therapy at Time of Laparotomy for Gynecologic Malignancies. Int J Gynecol Cancer. 2016 Oct;26(8):1525-9. doi: 10.1097/IGC.0000000000000792.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Giovanni Scambia, Professor principal investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS,Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAC therapy in people with Wound Infection and Gynecologic Cancer, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. 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 Italy. 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?
Results are not available in the source record.
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?
Change of the rate of surgical site infections at 15 days (time frame: 15 days). 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 NCT04584957, which also lists 11 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 14 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.