Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)

Gynecologic Cancer Clinical Trial

— GO-VAC  

Official title:

Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04584957
• Other study ID #: G.O-VAC. ID. 3316
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: September 18, 2021

Study information

• Verified date: October 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: September 18, 2021
• Est. primary completion date: September 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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])

• 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.

Exclusion Criteria:

• 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

• post-operative prophylactic use of antibiotics beyond the intraoperative short therapy

• contaminated (class III) and dirty/infected (class IV) incision [10]

• allergy to silver

Related Conditions & MeSH terms

• Gynecologic Cancer
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• VAC therapy
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli, IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Blackham 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. — View Citation

Kim 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. — View Citation

Kim 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. — View Citation

Lynam 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. — View Citation

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. — View Citation

Nugent 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. — View Citation

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. — View Citation

Scalise 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. Review. — View Citation

Semsarzadeh 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. — View Citation

Wechter ME, Pearlman MD, Hartmann KE. Reclosure of the disrupted laparotomy wound: a systematic review. Obstet Gynecol. 2005 Aug;106(2):376-83. Review. — View Citation

Willy 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 %.	15 days
Secondary	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	30 days
Secondary	Change of the rate of surgical site infections at 7 days	Evaluate and compare the wound healing rate at intermediate evaluation	7 days
Secondary	Estimated operative time	Evaluate and compare the time required for use of the operating room	1 day
Secondary	Estimated hospital stay	Evaluate and compare the duration of hospital stay	3-30 days
Secondary	Antibiotic therapy estimate	Evaluate and compare the proportions of patients requiring antibiotics because of wound complications	30 days
Secondary	Time to start adjuvant therapy	Evaluate and compare the time to eventual adjuvant therapies.	30-50 days