Treatment Trials

48 Clinical Trials for Various Conditions

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RECRUITING
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Description

This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.

RECRUITING
Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
Description

The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are: * Are there tissue thickness changes between the two groups (control group and augmentation group)? * Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed. Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.

COMPLETED
Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
Description

The purpose of this clinical trial is to assess if donor site healing in the palatal area and patient pain perception are similar or different when using amnio-chorion membrane (ACM) on the donor site after surgery compared to a commonly used commercial hemostatic agent (ActCel Cellulose Gauze).

Conditions
COMPLETED
A Trial Comparing a Cellulose Dressing to Two Standard of Care Dressings in Treating Split Thickness Donor Sites in Burn and Wound Patients.
Description

This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.

TERMINATED
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Description

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.

TERMINATED
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Description

Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function

Conditions
COMPLETED
The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
Description

A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.

ACTIVE_NOT_RECRUITING
PEP on a Skin Graft Donor Site Wound
Description

The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.

Conditions
ACTIVE_NOT_RECRUITING
CO2 Laser Revision for Burn Related Donor Site Scars
Description

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

COMPLETED
Impact of Prisma on Donor Site Pain
Description

The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.

TERMINATED
Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites
Description

The investigators aim to study whether Suprathel, a synthetic temporary skin substitute developed by PolyMedics Innovations GmBH aids in the management of patient pain and wound healing when compared to the current standard dressing used of a primary Xeroform dressing.

TERMINATED
The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
Description

The purpose of this study is to compare post-operative skin graft donor site pain between those treated with standard wound care vs PRP. Secondarily the study is designed to compare time to complete donor site healing. The null hypothesis is that here is no difference in post-operative donor site pain between those treated with standard wound care and PRP. The secondary null hypothesis is that there is no difference in time to donor site healing.

RECRUITING
Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
Description

Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.

COMPLETED
Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
Description

The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).

Conditions
TERMINATED
Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients
Description

Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to minimize that pain with local anesthetic as well as a combination of pain medications, the donor site pain lasts for days and is what patients often report as being the most painful part of their burn care. There has been the development of a new form of local anesthesia that can last up to 72 hours when injected into tissue. Based on encouraging results in the literature in areas outside of burns, this study aims to evaluate whether administration of this medication at the time of surgery can help improve pain for burn patients in the postoperative period.

TERMINATED
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
Description

To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.

Conditions
COMPLETED
Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites
Description

The hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (FGG) donor sites being covered by the test wound dressing material episil compared to the control dressing.

COMPLETED
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Description

Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.

Conditions
TERMINATED
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
Description

The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.

COMPLETED
Amniotic Membrane for Donor Site Healing
Description

The purpose of this study is to compare the effectiveness of applying amniotic membrane dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This study will enroll ten participants who undergoing a split thickness skin graft procedure with two or more donor sites. The amniotic membrane will be applied to one donor site and a dressing of xeroform and gentamicin will be applied to another other donor site. Each participant will receive both types of dressing and will serve as their own control. Postoperative follow up will follow standard of care, regardless of the dressing type. Dressings will be removed on postoperative day 4 and participants will return to be re-examined one week after being discharged from the hospital.

Conditions
COMPLETED
Arista for ALT Donor Sites to Reduce Drain Output
Description

This is a single-blinded multi-institutional randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites. Increased drainage from donor sites can lead to seroma formation with possible secondary infection, delayed hospital discharge, and additional home care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic powder that can be easily applied to broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to free flap donor sites may bear significant potential benefit. Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs and time to drain removal compared to ALT donor sites closed without Arista. Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will reduce postoperative ALT donor site seromas and patient hospital length of stay.

Conditions
COMPLETED
Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.
Description

Burn pain is known to be one the most severe forms of acute pain often requiring large amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for controlling pain in various settings including dressing changes of burns. The aim of this study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and narcotic requirements when applied to donor graft sites while at the same time not interfering with the standard of care TheraBond dressing. During this study the investiagtors will be monitoring for evidence of delayed wound healing, and surgical site infection.

Conditions
COMPLETED
Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery
Description

This study is to determine what dressing would work best to heal and keep from hurting, the split-thickness skin graft donor site which will be done as part of the patient's surgical procedure. Currently there is a dressing that is transparent and it is placed on the wound after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the gauze and elastic bandages are removed and the area is left with the transparent dressing. Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing is removed and the wound is left open to air. The dressing researchers are studying is a dressing that has been used for different types of wounds, as well as this type of wound. It is applied in the same manner; however, it is left in place until it falls off independently, usually around post-operative (post-op) day 10.

COMPLETED
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
Description

The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well. Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap. Healing should be asses after 10-14 days.

COMPLETED
Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
Description

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.

Conditions
WITHDRAWN
Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites
Description

Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.

COMPLETED
Split Thickness Donor Site Healing With MIST Study
Description

Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study eligibility. This study is a prospective, randomized, controlled trial evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites compared to standard care. Subjects meeting all eligibility criteria and providing appropriate written informed consent will be enrolled for study participation.

COMPLETED
Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites
Description

The primary objective of the study is to evaluate the time to wound healing in skin graft donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.

COMPLETED
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
Description

The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.

TERMINATED
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
Description

The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.

Conditions