Table 1 SAWHI inclusion and exclusion criteria

Written informed consent

Age <18 years

Diagnosis of post-surgical subcutaneous abdominal wound healing impairment

Expected non-compliance with study procedures, visit schedule, and follow-up

Minimum wound size eligible for both possible study treatment arms

Pregnancy

Inclusion, randomization and start of therapy within 48 hours after initial diagnosis

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 therapy and procedures at the time of inclusion