This study is initiated by the Department of Surgery of the Academic Medical Centre in Amsterdam, and is being conducted in several European countries. For this study, 388 patients will be needed. This study has been approved by the medical ethics committees in participating countries.
Goal of the trial
The goal of this trial is to investigate whether incisional negative-pressure wound therapy, a relatively new form of postoperative wound care, is effective at preventing postoperative wound complications after surgery where contamination of the operative field with bacteria is inevitable.
Background of the trial
Sometimes it is inevitable to operate without bacteria in the operative field, for example because of the necessity of opening bowel, or the presence of a stoma or fistula. This is called contaminated surgery. Postoperative wound complications after contaminated surgery are an important, yet frequent problem; up to 46% of patients develops postoperative wound complications after contaminated surgery. This leads to an increased disease burden, with a longer length of stay at the hospital and sometimes even a need for additional surgery. Although postoperative wound complications cannot be eliminated completely, there is evidence to suggest that incisional negative-pressure wound therapy is able to decrease the amount of postoperative wound complications. Because of a scarcity of randomized evidence investigating the efficacy of incisional negative-pressure wound therapy in contaminated surgery, the PRESSURE Trial has been initiated.
What participating in this trial mean for you as a patient
If you decide to participate in the trial, the length of participation will be one year. However, we also want to ask you for the possibility to contact you after your participation in the trial has ended, because it is very important to know the long term effects of the treatment you received, so physicians can take this information into account when treating future patients. At any time during the trial, you can decide to withdraw from participation without consequences. The length of your hospitalization will not be extended because of participation in the trial.
Wound care after surgery
Participants will be treated with two different kinds of wound care after surgery. Half of the patients will receive conventional wound care using a gauze-based dressing as is considered the standard of care. The other half of patients will receive incisional negative-pressure wound therapy. Patients will be assigned one type of treatment using a computer-based randomization program.
Data collection for the trial
Before the surgery, we will ask you to fill out a questionnaire which will take several minutes. This questionnaire is regarding Quality of life. We will ask you to fill out this questionnaire again after one month, three months, and one year after surgery.
Furthermore, we want to ask you to take a photo of your tummy before surgery, and every week thereafter for up to one month after surgery (5 photos), and three months and one year after surgery. When you visit the hospital for a problem with your wound, please take a picture as well. This will help us to investigate of the efficacy of wound care because this allows for blinded outcome assessment of the presence of recurrence or postoperative wound complications, which will reduce bias. Taking and sending the picture will take a few minutes per photo.
What is expected of trial participants
In order for the trial to result in better care for future patients it is important:
•To follow the instructions regarding your wound care;
•To fulfil appointment, questionnaires and photo obligations.
It is important to contact the trial coordinator:
•when you are being hospitalized;
•you change your contact information;
•when you no longer want to participate in the trial.
Possible discomfort
Incisional negative-pressure wound therapy is generally handled well by patients and is being described as comfortable. However, as with other dressings, there is a small chance your skin will develop a reaction against the dressing material. Please contact your physician when this is the case or when you have an acrylates or silver allergy.
Advantages or disadvantages of participation
It is important that you consider the advantages and possible disadvantages before you decide to participate in the trial. Incisional negative-pressure wound therapy may prevent you will develop postoperative wound complications, but this is not certain.
Disadvantages may be:
•The development of a skin reaction (<1% chance);
•The development of discomfort while wearing incisional negative-pressure wound therapy.
Participation also implies that you will have obligations and have to invest time answering the questionnaires and taking the photos.
If you do not want to participate
Only you decide whether you want to participate in the trial. Participation is voluntary.
If you do not want to participate, your wound care will be as is customary in your hospital.
Not participating will not affect the care you will receive in your hospital.
When you have decided to participate in the trial, you may change your mind during the trial.
You are free to discontinue participation in the trial at any time, but you will have to notify the trial coordinator. Data gathered before discontinuation of participation will be used for the trial.
End of the trial
Your participation in the trial will stop when:
•All data has been gathered (one year after surgery);
•You choose to discontinue participation;
•The trial coordinator or your treating physician think it is appropriate to discontinue your participation in the trial;
•The government or your local medical ethics committee decide to stop the trial.
The trial will be finished when all participants have one year follow-up available.
After the analysis of all data the trial coordinator will inform you of the most important outcomes of the trial. This will be six months after data accrual will be complete. It is estimated that the trial will take two and a half years.
Usage and storage of your personal information
It is necessary for the trial to collect personal (medical) information.
Every participant will be appointed a code which will be used to handle data anonymously. Your name and personal details will be left out.
Your data
Al the information gathered from you during the trial will remain confidential. Only the trial coordinator knows the code with which coded data can be traced to individuals. Every report about the trial will be anonymous.
Some individuals may access your medical and personal information but this will only occur for assessment of the conduct of the trial or when this regards your own safety.
Trial data will be kept for 15 years.
The trial is registered at Trialregister.nl
This website will provide a summary of the trial in the future but no data traceable to your personal identity will be published.
Participation reimbursement
When you will receive incisional negative-pressure wound therapy this will be free of charge. You will not receive reimbursement for participation in this trial.
Questions?
If you have any questions, please send an e-mail to pressure@amc.nl
