Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments (SAWHI)

The Institute for Research in Operative Medicine as part of the Private University of Witten /Herdecke and Kinetic Concepts Incorporated are performing a clinical study to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) Therapy for the treatment of postsurgical abdominal wound healing impairments after surgery. Therefore the underlying layer of fibrous tissue that permeates the internal organs must be intact.

Background of the study is the decision of a german authority, that is responsible for the reimbursement of medical therapies, (Joint Federal Committee of Germany) that Vacuum assisted closure therapy is inadmissible to be a standard benefit of health insurance companies in Germany.

Basis for this decision have been reports of the Institute for Quality and Economic Efficiency in the Healthcare System, which showed an insufficient state of evidence regarding the efficacy of negative pressure wound therapy for the treatment of acute and chronic wounds.

This study will be performed in several hospitals and countries to compare the efficacy of Vacuum Assisted Closure®-therapy with the methods of standard conventional wound therapy according to the existing hospital standard.

Main outcome measure is the time which is needed to achieve a complete and stabile wound closure. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters.

Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm.

The primary outcome measure (time until complete and confirmed wound closure) and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analysed under the use of a central computer system. The central analysing personal will not be informed about patient details or therapy allocation.

Based on already performed studies and the experiences of clinical practise V.A.C.®-therapy is suspected to be faster in achieving a complete and stabile wound closure than standard conventional wound therapy when used for the treatment of postsurgical abdominal wound healing impairments after surgery. Furthermore Vacuum Assisted Closure®-therapy is believed to be an effective and safe treatment option for abdominal wound healing impairments after surgery for inpatient as well as for outpatient care.

belly wounds Patients with at first closed belly wounds with wound healing disorder in the postoperative course after surgery without an opening of the underlying layer of fibrous tissue are eligible to be included in the trial if the diagnosis of a wound healing impairment in the postoperative course is manifested as a wound with spontaneous dehiscence, a wound that requires an active reopening of the suture by the treating physician or a wound that cannot be closed by primary intention and requires further treatment to achieve permanent closure.

Study participants will be selected and enrolled within clinical surgical departments which provide the respective personal, structural and scientific background for the conduction of the trial project.

Trial therapy will be started in-hospital and may be continued in ambulatory care. It is very important to examine the therapy options also in the ambulant care setting thus study participants with good health who are able to continue the specific wound treatment in ambulant should be transferred to the ambulant service as soon as possible.

The results of the study will be provided until the end of 2014 to make a contribution to the final decision of the Joint Federal Committee about Vacuum Assisted Closure® (V.A.C.®) Therapy to be a standard benefit of health insurance companies in Germany for inpatient and / or outpatient care.