TABLE 1.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Wound prior to informed consent	Pregnant (determined by a positive serum or urine pregnancy test at screening)	Received NPWT on the study wound within the last 30 days
Admitted as an inpatient	Life expectancy of <12 mo	Wound contraindicated with Protosan Wound Irrigation Solution
≥18 years of age	Not healthy enough to undergo surgery for any reason	Presence of hyaline cartilage in the wound
Able to provide informed consent	Any clinically significant condition that would impair ability to comply with study procedures	Malignancy in wound Untreated osteomyelitis
Willing and able to return for all scheduled and required study visits	Condition that would not allow the Subject to tolerate the therapy (eg, painful conditions such as vasculitis)	Non‐enteric or unexplored fistulas Necrotic tissue with eschar remaining in wound after debridement a
Wound requires operative debridement	Rheumatoid arthritis Bleeding disorder or coagulopathy Wound that contains antibiotic cement or beads	Unprotected, exposed blood vessels Anastomotic sites, organs, or nerves in direct contact with foam
Open wound >4 cm in any plane of measurement excluding tunnels after initial surgical debridement Wound appropriate for NPWT use	Ischaemic lower extremity wound (determined by lack of detectable pulses in the extremity or ankle‐brachial pressure indices of <0.9 with history of diabetes or < 0.6 if non‐diabetic)	Use of intervening layers between the wound bed and foam Wound in thoracic or abdominal cavities
No participation in a clinical trial within the past 30 days	Known allergy or hypersensitivity to V.A.C. Therapy dressing components (including polyurethane or polyvinyl alcohol [drape or foam])	Unexplored wounds that may communicate with adjacent body cavities Wound closed after initial debridement
30‐day wound history available if wound was previously treated	Known allergy or hypersensitivity to 3M Cavilon No Sting Barrier Film or any of its components (including hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethylsiloxane copolymer)	Known allergy or hypersensitivity to Prontosan or any of its components (including PHMB or undecylenamidopropyl betaine)

Abbreviations: NPWT, negative‐pressure wound therapy; PHMB, polyhexamethylene biguanide.

^aOnce necrotic tissue or eschar was removed from the wound, the subject could be included.