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Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by Vacuum-Assisted Closure® (V.A.C. ® SAWHI-Study) versus standard conventional wound therapy

Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by Vacuum-Assisted Closure® (V.A.C. ® SAWHI-Study) versus standard conventional wound therapy - SAWHI study: VAC2010-56

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35758
Enrollment
30
Registered
2011-08-01
Start date
2011-11-10
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onderhuids abdominale wondhelingsstoornis zonder fasciedehiscentie na operatie NA

Interventions

Either VAC or conventional wound therpay (through randomization).

Sponsors

University of Witten/Herdecke
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: There are 2 categories of Subjects with distinct post-surgical open abdominal wound diagnoses that will qualify for this study: • Subjects with primarily closed post-surgical abdominal wounds without fascial dehiscence that develop a spontaneous wound dehiscence or require an active reopening of the wound by the attending physician;• Subjects with open post-surgical abdominal wounds without fascial dehiscence that cannot be closed by primary intention and require further treatment to achieve permanent closure

Exclusion criteria

Exclusion criteria: Pregnant;Dehiscence of the abdominal fascia ;Any pre-existing or ongoing organ system failure;Active signs or symptoms of Abdominal Compartment Syndrome

Design outcomes

Primary

MeasureTime frame
The primary objective of this multicenter, parallel design, prospective, randomized clinical trial is to compare the clinical safety and economic outcomes of VAC therapy and SCWT in postsurgical abdominal wound healing impairments without fascial dehiscence.

Secondary

MeasureTime frame
Secondary endpoints are related to a number of wound healing variables (re-opened wound, wound size reduction), safety and quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)