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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.

Seidel D, Lefering R, Neugebauer EA - Trials (2013)

Bottom Line: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany.Further studies were therefore indicated.Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.

View Article: PubMed Central - HTML - PubMed

Affiliation: IFOM - Institute for Research in Operative Medicine, Faculty of Health - School of Medicine, University of Witten/Herdecke, Ostmerheimer Strasse 200, Building 38, 51109, Cologne, Germany. Doerthe.Seidel@uni-wh.de.

ABSTRACT

Background: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated.

Methods/design: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms.

Discussion: The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.

Trial registration: Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

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Related in: MedlinePlus

SAWHI-study flow chart. The figure shows the SAWHI overall study flow.
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Figure 1: SAWHI-study flow chart. The figure shows the SAWHI overall study flow.

Mentions: This multicenter study will be conducted in abdominal surgical hospital departments with the required manpower as well as structural and scientific qualifications. For both treatment arms, a maximum treatment time of 42 days to achieve complete wound closure shall be provided to cover 80% of participants, whether healing occurs by secondary or delayed primary closure [4]. All participants will be followed up for 90 days (three months) after the maximum treatment time, independent of whether a wound closure was achieved or not, or at which time point within the maximum timeframe for active treatment the wound closure was achieved. Thus, a general follow-up date for all study participants will be at Day 132. A follow-up period of three months after the active treatment period allows for an assessment of recurrence of the wound dehiscence or impairment as well as an adequate assessment of health economic relevant issues. Participants who have not achieved wound closure after 42 days will be seen at 45 days (six weeks) after the end of active treatment time (Day 87). This timeframe allows for a complete assessment of wound progression after study treatment and an assessment of wound closure that is achieved later than Day 42. Figure 1 gives an overview of the study flow. Study therapy will be started on participants in ambulatory care or in hospital and may be continued in ambulatory care. Due to the scope of the trial to evaluate outcomes and benefits of V.A.C.® Therapy when compared to SCWT when used across these care settings, all patients at the time point of randomization or inclusion, or during the active treatment period of 42 days that are eligible for outpatient care and have reasonable access to it, have to be transferred to outpatient care. The transfer of appropriate patients to outpatient care will be monitored and a missing transition that is not due to the medical condition of the patient or the need to provide the optimal treatment will be considered to be a protocol violation.


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.

Seidel D, Lefering R, Neugebauer EA - Trials (2013)

SAWHI-study flow chart. The figure shows the SAWHI overall study flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4225503&req=5

Figure 1: SAWHI-study flow chart. The figure shows the SAWHI overall study flow.
Mentions: This multicenter study will be conducted in abdominal surgical hospital departments with the required manpower as well as structural and scientific qualifications. For both treatment arms, a maximum treatment time of 42 days to achieve complete wound closure shall be provided to cover 80% of participants, whether healing occurs by secondary or delayed primary closure [4]. All participants will be followed up for 90 days (three months) after the maximum treatment time, independent of whether a wound closure was achieved or not, or at which time point within the maximum timeframe for active treatment the wound closure was achieved. Thus, a general follow-up date for all study participants will be at Day 132. A follow-up period of three months after the active treatment period allows for an assessment of recurrence of the wound dehiscence or impairment as well as an adequate assessment of health economic relevant issues. Participants who have not achieved wound closure after 42 days will be seen at 45 days (six weeks) after the end of active treatment time (Day 87). This timeframe allows for a complete assessment of wound progression after study treatment and an assessment of wound closure that is achieved later than Day 42. Figure 1 gives an overview of the study flow. Study therapy will be started on participants in ambulatory care or in hospital and may be continued in ambulatory care. Due to the scope of the trial to evaluate outcomes and benefits of V.A.C.® Therapy when compared to SCWT when used across these care settings, all patients at the time point of randomization or inclusion, or during the active treatment period of 42 days that are eligible for outpatient care and have reasonable access to it, have to be transferred to outpatient care. The transfer of appropriate patients to outpatient care will be monitored and a missing transition that is not due to the medical condition of the patient or the need to provide the optimal treatment will be considered to be a protocol violation.

Bottom Line: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany.Further studies were therefore indicated.Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.

View Article: PubMed Central - HTML - PubMed

Affiliation: IFOM - Institute for Research in Operative Medicine, Faculty of Health - School of Medicine, University of Witten/Herdecke, Ostmerheimer Strasse 200, Building 38, 51109, Cologne, Germany. Doerthe.Seidel@uni-wh.de.

ABSTRACT

Background: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated.

Methods/design: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms.

Discussion: The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.

Trial registration: Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

Show MeSH
Related in: MedlinePlus