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

Wound Healing Disorder Clinical Trial

— SAWHI  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528033
• Other study ID #: VAC2010-56
• Secondary ID: 00000648
• Status: Completed
• Phase: N/A
• Start date: August 2, 2011
• Est. completion date: June 11, 2018

Study information

• Verified date: June 2020
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Institute for Research in Operative Medicine as part of the Private University of Witten /Herdecke is planning and performing a clinical trial project to evaluate the efficacy of Vacuum Assisted Closure® (V.A.C.®) Therapy for the treatment of postsurgical abdominal wound healing impairments after surgery without fascial dehiscence. The clinical trial project is fully financed by Kinetic Concepts Incorporated (KCI). The V.A.C.® Therapy devices that will be used in this study include the ActiV.A.C.® Therapy System, InfoV.A.C.® Therapy System, and V.A.C. Freedom® Therapy System. All V.A.C.® Therapy devices to be utilized in this study bear the CE mark and will be operated within normal conditions of use and according to manufacturer's specifications.

Background of the clinical trial project is the decision of the Joint Federal Committee of Germany (Gemeinsamer Bundesausschusses (G-BA)) that Vacuum assisted closure therapy is inadmissible to be a standard benefit of health insurance companies in Germany.

This decision is based on systematic review & meta-analysis of existing trials performed by Institute for Quality and Economic Efficiency in the Healthcare System (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)) 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 project compares Vacuum Assisted Closure® and standard conventional wound therapy in the treatment of acute abdominal wounds after surgery without fascial dehiscence and will be conducted in abdominal surgical hospital departments with the required structural, manpower, and scientific qualifications. Patients will be stratified according to hospital and wound size. Trial therapy will be started in-hospital and may be continued in ambulatory care.

The study is designed as a multinational, multicentre, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint.

The primary objective is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT in postsurgical abdominal wound healing impairments without fascial dehiscence.

The primary outcome to be observed in this study is time to complete abdominal wound closure where closure is observed at or before day 42 and is confirmed to have been sustained for a period of at least 14 consecutive days. This study design also will allow detailed description of specific covariates to determine their effect on response variables (healing).

This study's hypothesis is that the use of the V.A.C.® Therapy System, when compared to SCWT in the management of post-surgical abdominal wound healing impairments with intact fascia, will result in a decrease in the time to achieve complete wound closure with confirmation after subsequent 14 days.

Using V.A.C.® Therapy is an effective and safe treatment option for hospitals as well as for outpatient care for treatment of subcutaneous abdominal wounds with wound healing impairment in the postoperative course.

Randomisation to treatment arms will be performed at a 1:1 ratio. Randomisation will be performed via a centralized system with an Internet-based tool. To address issues of blinding, wound photo documentation will be obtained during the trial and confirmation of wound closure will be assessed via blinded photographic analysis, which will serve as the method of primary endpoint analysis.

Primary closed abdominal wounds with wound healing disorder in the postoperative course after surgical intervention without fascial dehiscence 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.

During active recruitment phase, the pre-trial estimates indicate approximately 600 patients will be required to yield the target of 552 evaluable participants. Using an adaptive design study sample-size calculations will be re-estimated upon planed interim analysis of study data of 250 patients. Patients will be enrolled from approximately 25 centres in Germany, the United Kingdom, Belgium and the Netherlands.

The evaluation of the primary Endpoint defined as time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days and secondary endpoints including clinical endpoints like recurrences, safety endpoints, patient reported outcome parameters and economic-based outcome measures will provide data regarding efficacy and efficiency of NPWT therapy for the treatment of acute post-surgical abdominal wound healing impairment in hospital as well as in the ambulant setting.

The results of the study will be provided to make a contribution to the final decision of the Joint Federal Committee about NPWT to be a standard benefit of health insurance companies in Germany for inpatient and / or outpatient care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: June 11, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Post-surgical subcutaneous abdominal wound healing impairment

• Minimum wound size eligible for the application of the randomized treatment- Inclusion, randomization, adequate wound pre-treatment (Debridement) and start of therapy within 48 hours after reopening of the wound, diagnosis for nonclosable wound or in case of spontaneous wound dehiscence

Exclusion Criteria:

• Age < 18

• Noncompliance with study procedures, visit schedule and follow up

• Pregnancy

• Present or nonclosable defect of the abdominal fascia

• Any pre-existing or ongoing organ system failure, that cannot be stabilized or solved by appropriate medical treatment

• Necrotic tissue with eschar present

• Non-enteric and unexplored fistulas

• Malignancy of the wound

• Use of any other device based on the principle of negative pressure wound therapy on the study wound within = 8 days prior to screening

• Competing therapies or procedures

• Simultaneous participation in other clinical trials

Related Conditions & MeSH terms

• Abdominal Wound Healing Disorder
• Abdominal Wound Healing Impairment
• Acute Postsurgical Subcutaneous Wound
• Disease
• Impaired Wound Healing
• Wound Healing Disorder
• Wounds and Injuries

Intervention

Device:
• Vacuum Assisted Closure®
Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days. VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site. Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.

Other:
• Standard conventional wound therapy
Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Belgium	Department of Abdominal Surgery Gasthuisberg University Hospital	Leuven
Germany	Sana Klinikum Lichtenberg (Berlin)	Berlin
Germany	Unfallkrankenhaus Berlin Klinik für Allgemein- und Viszeralchirurgie	Berlin
Germany	St. Josef-Hospital gGmbH Universitätsklinikum der Ruhr-Universität Bochum	Bochum
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsklinikum des Saarlandes, Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie	Homburg
Germany	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität	Mainz
Germany	Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg Chirurgische Klinik	Mannheim
Germany	Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar	München
Germany	Ruppiner Kliniken GmbH	Neuruppin
Germany	Klinikum Ernst von Bergmann, Klinik für Allgemein- und Visceralchirurgie	Potsdam
Germany	Diakoniekrankenhaus Rotenburg	Rotenburg
Germany	Thüringen-Kliniken "Georgius Agricola" GmbH	Saalfeld
Germany	GRN-Klinik Sinsheim, Allgemein- und Viszeralchirurgie	Sinsheim

Sponsors (2)

Lead Sponsor	Collaborator
University of Witten/Herdecke	KCI Europe Holding B.V.

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (2)

Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, Talaulicar R, Gehrig T, Lehwald-Tywuschik N, Glanemann M, Bunse J, Hüttemann M, Braumann C, Heizman O, Miserez M, Krönert T, Gretschel S, Lefering R. Negative Pressure Wound Therapy vs C — View Citation

Seidel D, Lefering R, Neugebauer EA. 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: study protocol for a randomized controlled trial. Trials. 2013 Nov 20;14:394. doi: 10.1186/1745-6215-14-394. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Wound Closure	Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3); Complete wound closure is defined as: 100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures	42 days
Secondary	Incidence of Confirmed and Verified Wound Closure	Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)	42 days
Secondary	Recurrence	Recurrence of wound opening after confirmed wound closure	132 days

External Links

•   Sponsor
•   Study Website