Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment of Subcutaneous Abdominal Wound Healing Impairment After Surgery Without Fascial Dehiscence by Vacuum Assisted Closure™(SAWHI-V.A.C.® Study) Versus Standard Conventional Wound Therapy
Brief Summary: This clinical study is performed in several German, Dutch and Belgian hospitals to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) 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.

Main outcome measure is the time until complete wound closure that sustained for a minimum of 14 days. 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 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.

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.


Options:
A: Arm Label: Vacuum assisted closure; Type: EXPERIMENTAL; Interventions: Procedure: vacuum assisted closure | Arm Label: Axillary dissection; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Axillary dissection | Intervention Type: PROCEDURE; Name: vacuum assisted closure; Assigned to Arm(s): Vacuum assisted closure | Intervention Type: PROCEDURE; Name: Axillary dissection; Assigned to Arm(s): Axillary dissection
B: Arm Label: Vacuum Assisted Closure®; Type: EXPERIMENTAL; Interventions: Device: Vacuum Assisted Closure® | Arm Label: Standard conventional wound therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard conventional wound therapy | Intervention Type: DEVICE; Name: Vacuum Assisted Closure®; Assigned to Arm(s): Vacuum Assisted Closure® | Intervention Type: OTHER; Name: Standard conventional wound therapy; Assigned to Arm(s): Standard conventional wound therapy
C: Arm Label: Current Standard; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing | Arm Label: Negative Pressure Wound Therapy; Type: EXPERIMENTAL; Interventions: Device: Prevena (Negative Pressure Wound Therapy Device) | Intervention Type: DEVICE; Name: Prevena (Negative Pressure Wound Therapy Device); Assigned to Arm(s): Negative Pressure Wound Therapy | Intervention Type: DEVICE; Name: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing; Assigned to Arm(s): Current Standard
D: Arm Label: Vacuum-assisted closure (VAC); Type: EXPERIMENTAL; Interventions: Device: Vacuum-assisted closure | Arm Label: Standard sterile dressing; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard sterile dressing | Intervention Type: DEVICE; Name: Vacuum-assisted closure; Assigned to Arm(s): Vacuum-assisted closure (VAC) | Intervention Type: DEVICE; Name: Standard sterile dressing; Assigned to Arm(s): Standard sterile dressing

Answer: B