Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT06873867
Description: All the study participants were considered at risk for adverse events.
Frequency Threshold: 0
Time Frame: 6-week treatment period + 1-week follow-up. Total 7 weeks
Study: NCT06873867
Study Brief: Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Negative Pressure Wound Therapy In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed 0 None 0 52 8 52 View
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed 0 None 0 52 5 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Superficial wound infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation around wound NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
NPWT seal issues NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain during dressing change NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View