Health TrialsbyHealthPanel

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

ConditionWound Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.

Physicians will be plastic surgeons in the IU Health system

Disqualifiers

Patients with a history of breast cancer.

Patients with prior history of breast surgery.

Patients with a prior history of radiation to the chest wall/breast.

Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).

Trial design

Design model

Single group

Treatments tested in this trial

  • Sylk Wound Dressing

    Device

    Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.

  • Dermabond/Prineo Dressing

    Device

    Patients will have Silk bioprotein post-surgical dressing on one side of chest wall, and will have Dermabond/Prineo on the other side of chest wall. All patients will act as their own controls for this study. This means that all patients are both in the control group as well as the intervention group, given that these surgeries are bilateral in nature and one side of their chest will receive the interventional dressing and the other will receive the control dressing.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Sylk Wound DressingExperimental treatment 1 intervention
Group B: Dermabond/Prineo DressingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medical Adhesive-Related Skin Injury (MARSI)

This outcome will assess the incidence and time point postoperatively of MARSIs in both dressing types (Silk and Dermabond/Prineo) used on the chest walls of patients enrolled in this study. This will be determined via physical examination and photo documentation of patient surgical incisions.

Time frame
12 weeks postoperatively
2

Timeing of premature removal of postoperative dressing

This objective will the post-operative time at which dressings are removed due to adverse events and/or intrinsic properties of the dressing falling off prior to what was instructed by the operating surgeon. This will be determined by physical exam or via patient-reported outcomes

Time frame
12 weeks postoperatively
3

Postoperative wound infection and dehiscence

This objective will assess the incidence and time postoperatively of wound dehiscence or infection on the postoperative incisions of patients. This will be determined by clinical examination and documented photographs of patient's incisions.

Time frame
Any time up until 12 weeks postoperatively

Secondary outcomes

1

Subjective wound healing outcome by patient

Patients will have their subjective impression of how their scars heal via phone survey

Time frame
Patients will have their subjective opinions evaluated 1, 2, 4, and 8-12 weeks post-operatively via phone survey
2

Subjective wound healing outcome of scar by blinded plastic surgeons

Plastic surgeons not involved in the study/direct patient care will receive blinded postoperative photos of patient surgical scars to determine which side of chest, if any, had better wound healing/scar outcomes

Time frame
12 weeks postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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