Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment

Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With Vacuum-Pack-Technique vs. Abdominal Dressing

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00834314

Acronym

ABDOVAC

Enrollment

Registered

2009-02-03

Start date

2010-02-28

Completion date

2014-05-31

Last updated

2015-12-08

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

Conditions

Open Abdomen, Temporary Abdominal Closure

Brief summary

The primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called abdominal dressing versus vacuum-pack-technique) are equally effective in the treatment of open abdomen. Secondary purpose is the comparison of feasibility and economic aspects.

Interventions

PROCEDUREVacuum-Pack-technique for temporary abdominal closure

Negative-pressure-wound-therapy applying a method described by Brock, Barker et al 1995: Temporary Closure of Open Abdominal Wounds - the Vacuum Pack (see citations).

PROCEDUREAbdominal-dressing-technique for temporary abdominal closure

Negative-pressure-wound-therapy for temporary abdominal closure applying a device of KCI International (V.A.C.® Abdominal Dressing System). see: http://www.kci-medical.com/kci/corporate/kcitherapies/vactherapy/dressings/abdominal/#

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible

Exclusion criteria

* Technical reasons * unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique

Design outcomes

Primary

Measure	Time frame
Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)	until end of vacuum-therapy or death

Secondary

Measure	Time frame
length of vacuum-therapy	until end of vacuum-therapy or death
costs of vacuum-therapy	until end of vacuum-therapy or death
vacuum-therapy-related morbidity/complications	until hospital dismissal or death
post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)	12 weeks after hospital dismissal
recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay	12 weeks post hospital dismissal
total length of ICU-stay	until end of ICU-therapy or death

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026