N/A N=23 Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Ileostomy - Stoma · Colostomy Stoma
Primary: Trans Epidermal Water Loss — 39.0; 35.9 g/m^2/h
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=38 A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
Ileostomy - Stoma
Primary: Trans Epidermal Water Loss — 19.6; 20.7; 24.1 g/m^2/h
N/A N=22 An Exploratory Study Investigating Human Skin Reaction to Output
Ileostomy
Primary: Trans Epidermal Water Loss After Test of Patches. — 45.8; 22.9; 36.8; 19.6 g/m^2/h
N/A N=17 Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Dermatologic Complications
Primary: Skin Barrier Peel Force — 150; 215 grams
N/A N=22 Human Skin Test Model in Colostomists
Colostomy Stoma
Primary: Peel Force — 2.6; 2.1; 4.4; 3.4 Newton
N/A N=170 The Advocate Study
Ostomy
Primary: Stoma Related Cost of Care — 223.73; 260.19 USD
Phase 4 N=120 Parastomal Reinforcement With Strattice
Parastomal Hernia
Primary: Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. — 6; 7 participants
N/A N=31 Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Ileostomy - Stoma
Primary: Leakage (Percentage of All Baseplates With Leakage) — 34; 35 percentage baseplates with leakage
N/A N=25 Investigation of a Supporting Ostomy Product Intended for Leakage Detection
Stoma Ileostomy
Primary: System Performance Accuracy of Pictures — 122; 126; 24; 45 Pictures
N/A N=167 Prevention of Incontinence-associated Dermatitis
Incontinence-associated Dermatitis
Primary: Incidence of Incontinence-associated Dermatitis (IAD) — 18; 8; 5; 5 Participants
N/A N=12 Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Pressure Ulcer Prevention
Primary: Change in Skin Surface Temperature From Baseline — 3.1; 3.8; 3.0; 3.3 °C
Phase 4 N=27 A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Urostomy
Primary: Preference of Sensura vs Moderma — 45; 43 percentage of prefering the product
N/A N=112 Stoma Closure and Reinforcement Trial
Colon Cancer · Rectal Cancer · Ileostomy - Stoma
Primary: Number of Participants With Wound Occurrences — 0 Participants
N/A N=52 Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Ileostomy · Colostomy
Primary: Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". — 56.9; 10.6; 29.4; 27.7 percentage of subjects answering
Phase 4 N=3,017 Coloplast DialogueStudy
Stoma
Primary: Quality of Life (Scale 0(Worst)-100(Best)) — 1.8 units on a scale — p=<0.0001
N/A N=83 A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
Peristomal Skin Complication
Primary: The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3) — 1.8; 2.0 score on a scale — p==0.015
N/A N=74 Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery
Hidradenitis Suppurativa · Surgical Wound
Primary: Wound QOL Survey Score Over Time — 1.14; 0.94; 0.77; 0.66 score on a scale
Phase 3 N=30 Comparison of Two Urostomy Bags (2-piece).
Urostomy Patent
Primary: Preference of the Two Urostomy Products — 21; 4 participants
N/A N=298 Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Surgical Site Infection
Primary: Occurrence of Superficial Surgical Site Infection — 11; 21; 107; 128 Participants
Phase 4 N=21 Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Pressure Ulcers
Primary: Percentage of Wounds Healed — 63.1; 6.1 percentage of wounds
N/A N=100 Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation
Stoma Ileostomy · Stoma Colostomy
Primary: Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks — 1.57; 0.93 Number of leakages per two weeks…
N/A N=38 Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Colorectal Cancer
Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
Phase 4 N=122 Performance Study of Newly Developed Ostomy Products
Stoma Colostomy
Primary: Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full…
N/A N=109 Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
Port-A-Cath Placement · Octylcyanoacrylate
Primary: Number of Participants With Complication of Wound Dehiscence — 0; 0 participants
N/A N=105 Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
Wound Infection
Primary: Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond — 41; 54 Participants
N/A N=10 Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)
Transfemoral Amputation
Primary: Bacterial Community Types as Determined by Percentage RNA Sequence Reads — 3.4; 4.6; 4.7; 8.7 Percentage RNA sequence reads — p=<0.05
N/A N=42 Durability of Two Skin Barrier Protectants (SBP)
Skin Hydration in Healthy Volunteers
Primary: Duration — 36.71; 36.31; 7.95; 20.98 arbitrary units
N/A N=144 Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Pressure Ulcers · Spinal Cord Injuries
Primary: Percent of Possible Self-Reported Skin Care Behaviors — 73.8; 74.1; 83.5; 79.5 % of Possible Self-Reported Behaviors
N/A N=47 Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Surgical Stomas
Primary: Leakage Through Coupling Registered at Each Bag Change (Yes/no) — 0.151; 0.237 Proportion of bag changes/participant — p=0.164
Phase 3 N=54 Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Colostomy
Primary: Leakage (Percent of All Base Plates With Leakage) — 27; 30 Percent of Base plates