Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558240
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The wound of cesarean section involves multiple layers of tissue and often cause significant postoperative pain The epidermal wound typically heals within 1 to 2 weeks after surgery In current clinical practice advanced wound dressings are commonly used for postoperative wound care The theory of moist wound healing was first proposed by Winter in 1962 advocating that maintaining a moist environment around the wound can accelerate the healing process
HERADERM Hydrogel Wound Dressing Sterile was approved by the Taiwan FDA in 1999 Although HERADERM Hydrogel Wound Dressing Sterile are frequently used clinically for post-cesarean section wound care there have been no comprehensive reports evaluating the effectiveness and clinical application of the dressings to date The purpose of this study is to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing on caesarean section surgical site and to provide user experience and clinical data for reference by patients and clinical personnel
HERADERM Hydrogel Wound Dressing Sterile was approved by the Taiwan FDA in 1999 Although HERADERM Hydrogel Wound Dressing Sterile are frequently used clinically for post-cesarean section wound care there have been no comprehensive reports evaluating the effectiveness and clinical application of the dressings to date The purpose of this study is to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing on caesarean section surgical site and to provide user experience and clinical data for reference by patients and clinical personnel
Detailed Description:
In this observational prospective single-arm study We aimed to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing Sterile on caesarean section surgical site Written informed consent are obtained before subjects participate in the study Eligible subjects will be taken initial wound photos and use experimental dressings for postoperative wound care after closure of caesarean section wound site To evaluate the clinical applicability of the experimental dressings wound healing assessments will be conducted by independent study nurse during the postoperative period hospitalization and follow-up visits Information of pain intensity experienced by subjects during dressing removal will be collected Additionally satisfaction surveys based on subjects experiences of wearing and changing the experimental dressings will also be collected during the hospitalization and follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None