Wounds and Injuries

All Conditions

Infections

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Communicable Diseases

Surgical Wound

Surgical Wound Infection

Wound Infection

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Postoperative Complications

Pancreatic Cancer

In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.

In the participants randomized to this arm the surgical site will be closed using the standard closure technique.

Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound

Prevena Peel & Place Dressing

This would involve standard closure of the incision site

Standard Closure of the Surgical Incision

Matthew J Weiss, MD

Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications. A retrospective study at Hopkins on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection. Patients with these factors having a predicted risk of up to 32%. Another subsequent retrospective study demonstrated that the use of negative pressure wound therapy device was significantly associated with a decrease in the rate of SSIs.

The hypothesis of the investigator(s) for the current study is that placement of Prevena Peel \& Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in their SSI rate.

Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a high perioperative complication rate. Surgical site infection is one of the most common complications after pancreaticoduodenectomy. In a retrospective review of all patients who underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679 patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis, perioperative blood transfusion, operative time greater than 7 hours, preoperative chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure device, and vascular resection were associated with surgical site infection (all, p\<0.05). On multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection (all, p\<0.001). Studies in colorectal patients have found an estimated cost of up to $1400 per patient secondary to prolonged hospitalization, wound care, and wound complications in patients with procedures complicated by a surgical site infection. Furthermore, in another study of 1144 patients undergoing pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative complications delayed time to adjuvant therapy, decreased median survival.

The hypothesis of the investigator(s) is that placement of Prevena Peel \& Place Dressing using the standard Acelity vacuum dressing after suture on patients undergoing pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in surgical site infection rate. The investigator(s) plan to perform a randomized control trial where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will undergo closure with Prevena Peel \& Place Dressing using the standard Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then follow the participant(s) for 30 days postoperatively to determine surgical site infection and other perioperative complication rate.

Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections

A Randomized Control Trial of Prevena Peel & Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement

Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)

Length of stay of patient at the hospital from date of surgery

Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery

Johns Hopkins University

In the participants randomized to this arm the surgical site will be closed using Prevena Peel \& Place Dressing.

Prevena Peel \& Place Dressing: Prevena Peel \& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound

Prevena Peel & Place Dressing for Wound Closure

In the participants randomized to this arm the surgical site will be closed using the standard closure technique.

Standard Closure of the Surgical Incision: This would involve standard closure of the incision site

Standard Closure of the Wound

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Neoadjuvant therapy

The patients were graded according to the American Society of Anesthesiologists risk scoring system. Patients are scores between I and IV based on their operative risk.

ASA I: A normal healthy patient. ASA II: A patient with a mild systemic disease. ASA III: A patient with a severe systemic disease that is not life-threatening. ASA IV: A patient with a severe systemic disease that is a constant threat to life.

American Society of Anesthesiologists (ASA) class

Preincisional prophylactic antibiotic

Preoperative biliary stenting

The study was conducted at a high volume center for pancreatic surgery with a broad experience using Negative-Pressure Wound Therapy (NPWT), and therefore there is a question about the generalizability of the reductions we observed.

Dr. Matthew J. Weiss

Rate of Surgical Site Infection

Prolonged Length of Stay, Measured in Days

Rate of Readmission for Surgical Site Infections (SSIs)

30-d Readmission

Overall Study

Skin and Connective Tissue Diseases

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment

The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.

CG428

Juhee Cho, PhD

We would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included. After completion of VOLUME study, the study will be directly extend with an "open-label design". All participants, who agreed to pursue, with either "Placebo" or "CG428", will receive CG428 treatment for an additional six-month period. VOLUME-2 study would be ideal and timely by enabling no interruption of product use.

The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months : 6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder populations.

Secondary Objectives are :

* Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant progression)
* Evaluate motivation and adherence of subjects
* Long term safety

The research team at Cancer Education Center at Samsung Comprehensive Cancer Center has studied CIA and its impact on distress and psychosocial well-being since 2008. We found that more than half of the breast cancer patients experienced higher distress due to CIA, during cancer treatment, and this distress was strongly associated with negative body image, overall health status, and psychosocial well-being. In a recent prospective cohort study, we assessed skin and hair change patterns before, during and 6 months after chemotherapy in 61 volunteers.

We found that the majority of the patients still experienced CIA at 6 months after completion of chemotherapy. Actually, hair diameter at 6th month after chemotherapy had not recovered to baseline level. Permanent chemotherapy-induced alopecia, defined as absent or incomplete hair regrowth at ≥6 months post-chemotherapy, was reported from 53 to 74%. Like CIA, permanent CIA also lacks recognition and has been underserved regardless of patients' needs. The first botanical blend Legacy Healthcare developed and patented is Cellium. Cellium is composed of 4 botanicals (Allium cepa L., Citrus limon L., Theobroma cacao L., Paullinia cupana).

The first product derived from Cellium is a topical lotion for male and female alopecia, CG210. Based on the safety and efficacy data, the EMA (European Medicines Agency) has considered CG210 eligible for a European centralized herbal medicine registration. CG428 is the second product derived from Cellium. CG428 contains the exact same ingredients as CG210, in a different dosage. Legacy Healthcare have conducted a pilot studies with CG428 in Japan. The trial included female cancer survivors experiencing permanent/persistent CIA for more than 12.

Based on the results, several cancer treatment centers in Japan have started to recommend the product on a compassionate basis.We therefore hypothesize that the investigated topical lotion may mitigate the impact of protracted or permanent CIA in cancer survivors by restoring a normalized apoptotic process of hair follicular cells and reducing the acute, as well as chronic inflammation in the scalp, two issues that may remain unsettled following anticancer treatment. While considering the subjects included in the "VOLUME" study, it appears that a majority of cancer survivors did not recover a full hair pattern even 3 years after cancer treatment. This is per se an interesting data, and a new and significant knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than anticipated.

While considering the subjects included in the "VOLUME" study, it appears that a majority of cancer survivors did not recover a full hair pattern even 3 years after cancer treatment. This is per se an interesting data, and a new and significant knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than anticipated.

The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.

To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.

This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.

This is a open-label, single center, observation study in breast cancer survivors of VOLUME participants.

Hair condition and parameters of 31 breast cancer survivors who were previously included in VOLUME study (a randomized controlled trial to evaluate effect of CG428 which is topical hair lotion for chemotherapy induced alopecia completed in December, 2016) will be assessed.

The participation du extension Volume-2 study will be proposed to patients during the last visit of Volume study (Month 6)

The "VOLUME" study could have in fact two major repercussions: in addition to give information on CG428 efficacy, it will help to better define persistent CIA and improve thereby our scientific knowledge of this condition. Considering the high prevalence and poor literature on persistent CIA, it appears important to study this condition further.

To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included.

This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months Volume-2) permitting to better discriminate later or non-responder populations.

A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)

Evaluation of the Impact of a Topical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer Survivors: An Open-label 6 Months Extension of VOLUME Study.

Information about what group they belonged to in previous studies

Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM

Respondents will be instructed to indicate on a 4-point Likert scale on each

Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D

Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module

We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.

We will ask how much to willing to pay for CG428

Outcomes will be collected using objective methods and patient reported outcomes:

Objectively quantified: Hair thickness and density: We will measure hair thickness and density using Folliscope 4.0, LeadM We will take a picture on the parietal (To around 2 cm) and then analysis using Folliscope program.

Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections	NCT03021668	Surgical Site I... Pancreatic Neop... Pancreatic Canc... Chemotherapy Ef... Chemoradiation Surgical Wound Wound Complicat...	Prevena Peel & ... Standard Closur...	18 Years -	Johns Hopkins University
A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)	NCT02986412	Alopecia Chemotherapy Ef...	CG428	19 Years - 70 Years	Samsung Medical Center

Spots Global Cancer Trial Database for chemotherapy effects