Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 27, 2007

Primary Completion Date

September 5, 2008

Study Completion Date

September 5, 2008

Conditions
Postoperative Pain
Interventions
DRUG

Bupivacaine Collagen Sponge (CollaRx®)

The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

DRUG

placebo

The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

Trial Locations (1)

27103

Forsyth Medical Centre - OB Anesthesia, Winston-Salem

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Innocoll

INDUSTRY

NCT00624910 - Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy | Biotech Hunter | Biotech Hunter