This group will receive the standard of care treatment for their distal humerus fracture only.

This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.

Heterotopic Ossification

Humeral Fractures

Radiation Therapy

A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively

Radiation

University of Louisville Hospital

HO Prophylaxis Therapy for Distal Humerus Fractures

Prophylaxis Low-Dose Radiation Therapy for Heterotopic Ossification in Distal Humerus Fractures

Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham

Rate of non-union of both groups requiring revision surgery.

Rodolfo Zamora, MD

Assistant Professor of Orthopaedic Surgery

University of Louisville

Participants will be randomized to either a treatment or control group.

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

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

Wound of Skin

Wound Heal

Surgical Wound

Full Thickness Skin Graft Healing

Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.

0.25% timolol gel with full-thickness skin grafts

Vaseline will be applied to wound bed immediately after surgery before dressing is applied.

Vaseline dressing

Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital

Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes

Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes: A Randomized, Controlled Trial

A study physician will review the healed scar site to determine if there are potential cosmetic factors that could be improved through scar revision. If the patient is interested in having scar revision procedures, the study physician will offer a dermabrasion or PDL to treat the scar site.

Physician blinded to subject's treatment group uses VSS which documents scar appearance change over time via photos. VSS ranges from 0 (most desirable outcome) to 13 (least desirable). A lower score is considered a better outcome and a higher score is a worse outcome. VSS consists of 4 sub-scales, with each reporting a value. The "pigmentation" ranges from 0 (normal pigment) to 2 (hyperpigment); "vascularity" ranges from 0 (normal appearance) to 3 (purple appearance); "pliability" ranges from 0 (normal) to 5 (contracture); "height" ranges from 0 (normal/flat) to 3 (>5mm). Sub-scale scores are combined to give an overall VSS score.

Scar VAS rates subjects' graft cosmetic appearance. Each question ranges from 1 (no complaints w/ itch or pain/as normal skin) to 10 (worst imaginable itch or pain/very different from normal skin). Ranges from 6 (best outcome score) to 66 (worst outcome score); a lower score is considered a better outcome and a higher score is considered a worse outcome.

The Graft Take Score will be used to assess amount of graft take at each visit. Graft take is considered "Good" if 90%+ of the graft site is healed and pink/purple in color; "Moderate" if there is 50% healing, pink or purple in color, and >50% of the graft has taken; and "Poor" if <50% graft take.

Histogram planimetry is more accessible than automated analysis software programs, and it is based on the pixel count of a selected irregular area which is divided by the pixel count of 1 cm2 to find a result in terms of cm2 or mm2.

Subjects will be asked to complete a Visual Analogue Scale for scar assessment to rate how they think their graft sites appear cosmetically compared to normal skin, and any complaints about how painful they sites are, and how itchy they feel. Each question ranges from 1 (no complaints with itch or pain/as normal skin) to 10 (worst imaginable itch or pain/very different from normal skin). The score ranges from 6 (best outcome score) to 66 (worst outcome score), thus a lower score is considered to have a better outcome and a higher score is considered a worse outcome.

A physician will assess for side effects and determine whether they are likely associated with the 0.25% topical timolol or part of the normal wound healing experience.

Patients will report any side effects they experience post-surgery

Chrysalyne D Schmults, MD, MSCE

Director, Mohs and Dermatologic Surgery Center

Brigham and Women's Hospital

The protocol will begin post-surgery. Eligible subjects will be assigned by computer-based randomization to case (0.25% timolol gel) or control (standard of care [SOC]) group and treated as follows:
Receiving site of FTSG/case group:
During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed
During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft
After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks
Receiving site of FTSG/control group:
FTSG surgery as per SOC
After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

burns/phosphatase

HO Prophylaxis Therapy for Distal Humerus Fractures

Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes

Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury

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