Juvidex (Mannose-6-Phosphate) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites

Summary

The objective of this study is to compare the efficacy of two concentrations of Juvidex with placebo on the healing of split thickness skin graft donor sites

Conditions

• Wound

Interventions

DRUG

Mannose-6-Phosphate (Juvidex)

* 100µL of 300mM (8.46 mg/100μL) Juvidex will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of 300mM (8.46 mg/100μL) Juvidex will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest. * 100µL of placebo will be injected intradermally into each cm2 of the other 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.

DRUG

Mannose-6-Phosphate (Juvidex)

* 100µL of 600mM(16.93 mg/100μL) Juvidex will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of 600mM (16.93 mg/100μL) Juvidex will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest. * 100µL of placebo will be injected intradermally into each cm2 of the other 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest.

DRUG

Mannose-6-Phosphate (Juvidex)

* 300µL of 300mM (8.46 mg/100μL) Juvidex will be applied topically to one 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest. * 300µL of placebo will be applied topically to the other 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest.

DRUG

Mannose-6-Phophate (Juvidex)

* 300µL of 600mM (16.93 mg/100μL) Juvidex will be applied topically to one 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest. * 300µL of placebo will be applied topically to the other 3cm2 donor site within 30 minutes of graft harvest and 24 hours after graft harvest.

DRUG

Placebo

* 100µL of placebo will be injected intradermally into each cm2 of one 3cm2 donor site and into the 0.5cm border around the donor site no more than 20 minutes before graft harvest (total dose 750µL). A further 300µL of placebo will be applied topically within 30 minutes of graft harvest and 24 hours after graft harvest. * Standard Care (moist wound healing dressings alone) will be applied to the other 3cm2 donor site.

Sponsors & Collaborators

• Renovo

  lead INDUSTRY

Principal Investigators

• Jim Bush, MBChB. MRCS · General Medical Council

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2008-10-31

Completion

2008-11-30

Countries

• United Kingdom

Study Locations