Infections

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Communicable Diseases

Wound Infection

Surgical Wound Infection

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

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

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

Giovanni Scambia, Professor

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.

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.

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)

The investigator check the random list only when the patients is enrolled

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

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

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 %.

Evaluate, compare and describe wound complications through the systematic performing of surgical wound swab at 7, 15, 30 days after surgery

Evaluate and compare the wound healing rate at intermediate evaluation

Evaluate and compare the time required for use of the operating room

Evaluate and compare the duration of hospital stay

Evaluate and compare the proportions of patients requiring antibiotics because of wound complications

Evaluate and compare the time to eventual adjuvant therapies.

Catholic University of the Sacred Heart

Professor

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Rare Diseases

Syndrome

Congenital Abnormalities

Cerebrospinal Fluid Leak

Spinal Dysraphism

Neural Tube Defects

Spina Bifida Occulta

Nervous System Malformations

Tethered Cord Syndrome

Split Spinal Cord Malformation

Lipomyelomeningocele

Spina Bifida

Natriuretic Agents

Anticonvulsants

All Drugs and Chemicals

Acetazolamide

Carbonic Anhydrase Inhibitors

Enzyme Inhibitors

Diuretics

administration of Acetazolamide for 10 days following the surgery

Positioning the patient following surgery for 10 days

applying both Acetazolamide and prone positioning

Acetazolamide administration for 10 days adjust dosage with weight of the patient

prone positioning the patient for 10 days following the surgery

prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Acetazolamide+ prone positioning

Farideh Nejat, MD

Shima Shahjouei, Student

* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

  * Group A: Acetazolamide administration for 10 days
  * Group B: prone positioning for 10 days
  * Group C: Acetazolamide administration and prone positioning for 10 days
  * Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.

leakage of CSF during 1 months following surgery

collection of the CSF beneath the skin during 1 month following the surgery

dehiscence of the surgical wound during the first month following surgery

Tehran University of Medical Sciences

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Necrosis

Historical cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and where negative wound pressure therapy has been omitted

Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy

Wound dressing with negative pressure on closed incisions

Negative pressure wound therapy

To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial

Rationale:

Patients and breast cancer surgeons are frequently confronted with complications after mastectomy. These complications are manifold and mainly consist of: surgical site infections, seroma, wound dehiscence and wound necrosis. These complications are caused by numerous variables and therefore a multifactorial approach is required. Due to extensive research over the years, insight has been gained in how to reduce the rate of surgical site infections and wound healing problems. For example, pre-operatively and intra-operatively the complication rate can partly be influenced by optimizing intrinsic patient factors before surgery and using prophylactic antibiotics (1). There is however room for improvement in the postoperative phase. Negative pressure wound therapy (NPWT) has proven to be useful in reducing wound complications in all sorts of wounds. Limited evidence has been published on NPWT after breast cancer surgery and the effect of such in reducing wound complications.

This is a pilot study to evaluate the effect of negative pressure wound therapy in reducing postoperative wound complications after mastectomy, which might serve as a basis for a randomized controlled trial..

Objective:

To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial

Study design:

A prospective cohort will be compared to a historical control group. Fifty consecutive patients will undergo mastectomy with flap fixation using tissue glue and skin sutures, closed suction drainage AND Avelle negative pressure wound therapy.

These results will be compared to the results of a historical control group consisting of 112 patients who have undergone mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and in whom negative wound pressure therapy was omitted.

Follow-up will be conducted for three months post mastectomy.

Study population:

Female patients \> 18 years diagnosed with invasive breast cancer or DCIS ( ductal carcinoma in situ) with an indication to perform mastectomy.

Intervention (if applicable):

Application of Avelle negative pressure wound therapy after standard mastectomy with flap fixation and closed suction drainage.

Main study parameters/endpoints:

Patients with postoperative wound complications during the first three postoperative months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at one week and three months. Additional study postoperative check-up will be performed at six weeks. Therefore, patients will be required to undergo one additional check-up. During out patients' visits, wound complication will be evaluated. Application of Avelle negative pressure wound therapy is expected to reduce wound complications and thereby benefit the post mastectomy wound healing process. The only potential risk for the patient is that the wound therapy would be ineffective or that the patient could develop an allergic reaction to the product. The latter is also a known risk of standard wound dressings.

A prospective cohort will be compared to a historical control group.

The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy

The Risk of Postoperative Wound Complications Following the Use of Avelle Negative Pressure Wound Therapy in Patients Undergoing Mastectomy and Flap fiXation: a Pilot Study

Number of patients with post-operative wound complications defined as follows:

1. Surgical site infection (SSI) is defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months.
2. Wound necrosis. Defined as a wound with necrotic tissue that consists of an accumulation of dead cells, tissue and cellular debris and often requires debridement.
3. Wound dehiscence or breakdown defined as a wound that ruptures along a surgical incision and the edges of the wound no longer align.

Number of unplanned visits to the ER or breast cancer clinic. Planned visits are standard follow-up outpatient clinic visits which are defined preoperatively. Unplanned visits are defined as any visit to the outpatient clinic which is necessary due to an adverse event.

Number of patients with clinically significant seroma. This is defined as:

1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis)
2. There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin.
3. There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)	NCT04584957	Wound Infection Gynecologic Can...	VAC therapy	18 Years - 100 Years	Catholic University of the Sacred Heart
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence	NCT01867268	Fibrolipoma of ... Lipomyelomening... Split Cord Malf... Dermal Sinus Tethered Cord S... Tumor	Acetazolamide prone positioni... Acetazolamide+ ...	- 18 Years	Tehran University of Medical Sciences
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy	NCT03942575	Breast Cancer Wound Complicat... Wound Infection Wound Dehiscenc... Wound Necrosis	Negative pressu...	18 Years -	Zuyderland Medisch Centrum
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy	NCT03942575	Breast Cancer Wound Complicat... Wound Infection Wound Dehiscenc... Wound Necrosis	Negative pressu...	18 Years -	Zuyderland Medisch Centrum

Spots Global Cancer Trial Database for wound dehiscence