0.25% timolol gel with full-thickness skin grafts for Surgical Wound (FTSG Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months' post-surgery and 6 months' post-surgery

Awards & highlights

No Placebo-Only Group

Summary

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the academic literature. The investigators will enroll 82 patients who have their skin cancer surgically removed resulting in the need of a full-thickness skin graft. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in full-thickness skin grafts compared to standard of care.

Eligible Conditions

Surgical Wound
Full Thickness Skin Graft Healing
Cuts
Wound Healing

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months' post-surgery and 6 months' post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months' post-surgery and 6 months' post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months' post-surgery and 6 months' post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluating the need for further scar revision (via dermabrasion or pulsed dye laser (PDL))

Secondary study objectives

Determining change in the side effects associated with 0.25% timolol gel versus SOC via patient assessment

Determining change in the side effects associated with 0.25% timolol gel versus SOC via physician assessment

Evaluating change in healing response to treatment with 0.25% topical timolol gel versus SOC in terms of wound surface area at the receiving site of a FTSG via Graft Take Score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 0.25% Timolol gel applied to full-thickness skin graftExperimental Treatment1 Intervention

1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks

Group II: Standard of Care dressingsActive Control1 Intervention

1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

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