18 and older, any sex, with Wound Healing Disorder or Impaired Wound Healing. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Complete Wound ClosurePrimary· 42 days
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
Group
Value
95% CI
NPWT
36.1
35.0 – 37.2
SCWT
39.1
38.3 – 40.0
Incidence of Confirmed and Verified Wound ClosureSecondary· 42 days
Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)
Group
Value
95% CI
NPWT
92
SCWT
54
RecurrenceSecondary· 132 days
Recurrence of wound opening after confirmed wound closure
Group
Value
95% CI
NPWT
0
SCWT
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Witten/Herdecke
Last refreshed: 25 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01528033.