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

NCT04584957 | Unknown DMC

• 1 other identifier: G.O-VAC. ID. 3316
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Infection; Gynecologic Cancer

Keywords

Gynecologic oncologic laparotomic surgery; Prophylactic negative pressure wound therapy; Surgical site infection; Wound dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Wound complications at 30 days

  30 days

• Change of the rate of surgical site infections at 7 days

  7 days

• Estimated operative time

  1 day

• Estimated hospital stay

  3-30 days

• Antibiotic therapy estimate

  30 days

Study Arms (2)

VAC therapy

ACTIVE COMPARATOR

Prophylactic ciNPWT therapy positioning YES. Patients enrolled for placement of the device over a closed incision immediately post-operatively.

Device: VAC therapy

Standard Closure

NO INTERVENTION

Prophylactic ciNPWT therapy positioning NO. Patients enrolled for standard laparotomic closure without ciNPWT positioning

Interventions

VAC therapy DEVICE

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.

VAC therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, RM, Italy

Location

Related Publications (11)

• 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.

  PMID: 12603990 BACKGROUND

• Wechter 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.

  PMID: 16055590 BACKGROUND

• 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.

  PMID: 21324517 BACKGROUND

• 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.

  PMID: 24388401 BACKGROUND

• 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.

  PMID: 25386858 BACKGROUND

• 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.

  PMID: 26424609 BACKGROUND

• 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.

  PMID: 27170231 BACKGROUND

• 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.

  PMID: 26313829 BACKGROUND

• 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.

  PMID: 23375758 BACKGROUND

• 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.

  PMID: 27488215 BACKGROUND

• 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.

  PMID: 24681712 BACKGROUND

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Scambia, Professor

  Fondazione Policlinico Universitario A. Gemelli, IRCCS,Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator check the random list only when the patients is enrolled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 14, 2020
• Study Start: September 18, 2020
• Primary Completion: September 18, 2021
• Study Completion: September 18, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

IT (1)