CompletedPhase 2

Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery

Denmark, Germany138 participantsStarted 2009-12

Plain-language summary

The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.

Age range15 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
✓. Open flexor tendon injury sutured within 14 days after trauma
✓. 12-75 years of age
✓. Signed informed consent prior to any study related procedures

TAM2

Timeframe: At 12 weeks after surgery

NCT IDNCT01022242

SponsorPergamum AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

Results submitted2014-02-04