To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site

NCT06558240 | Completed

• 1 other identifier: 2024-08-023AC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Surgical Wound; Surgical Wound Infection; Wounds and Injuries

Keywords

cesarean section; wound healing; HERADERM Hydrogel Wound Dressing (Sterile); surgical site infection; wound care

Outcome Measures

Primary Outcomes (2)

• REEDA scale

  The scale includes five factors that indicate abdominal wound healing: redness, edema, ecchymosis, discharge, and approaching wound edges. Each improvement factor is evaluated by giving 0, 1, 2 and 3 points. The sum of the scores obtained as a result of the evaluation of five categories constitutes the REEDA score. The lowest score on the scale is 0, and the highest score is 15. The highest score on the scale indicates severe perineal trauma.

  Assessing on post-operative day 2, 4 & 11

• Percentage of surgical wound infection

  The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection.

  Assessing on post-operative day 2, 4 & 11 if there are any surgical site infection

Secondary Outcomes (5)

• Percentage of allergic reaction to experimental dressings

  Within 11 days after surgery

• Intensity of pain during dressing removal

  Assessing on post-operative day 2, 4 & 11

• Incidence of adverse events

  Within 11 days after surgery

• Number of dressing change

  Within 11 days after surgery

• Satisfaction survey

  Assessing on post-operative day 2, 4 & 11

Study Arms (1)

Experimental: HERADERM Hydrogel Wound Dressing (Sterile)

Eligible subjects will use experimental dressings for postoperative wound care after caesarean section. The subjects received dressing change on the second day after surgery and on the day of discharge. After discharge, subjects will take home 2 pieces of experimental dressings and change by themselves. (Timing to change dressing after discharge: the area of exudate exceeds two-thirds of the dressing area)

Device: HERADERM Hydrogel Wound Dressing (Sterile)

Interventions

HERADERM Hydrogel Wound Dressing (Sterile) DEVICE

HERADERM Hydrogel Wound Dressing (Sterile) is a transparent, composite hydrogel dressing. The outer layer is a waterproof and breathable polyurethane film (PU film), which can prevent external bacterial invasion and reduce the risk of infection. The inner layer is A+ polymer hydrogel, which can keep the wound bed in a moist state and reduce the infiltration problem caused by wound exudate.

Experimental: HERADERM Hydrogel Wound Dressing (Sterile)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects going to undergo cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects going to have cesarean section in Taipei Veterans General Hospital.

You may qualify if:

• Age over 18, scheduling for a transverse incision cesarean section, and using HERADERM Hydrogel Wound Dressing (Sterile) for wound care at the end of the surgery.
• Gestational age over 37 weeks on the day of the cesarean section.
• Body mass index (BMI) less than 35 kg/m² on the day of the cesarean section.
• Subjects must be able to comply with follow-up wound care visits and subsequent monitoring.

You may not qualify if:

• Subjects unwilling to sign the consent form or with poor compliance.
• Currently suffering from severe immune-related skin diseases, such as severe urticaria, generalized eczema, pemphigus, lupus erythematosus, etc.
• Using medications that affect wound healing (e.g., glucocorticoids, anticoagulants and immunosuppressive drugs).
• Subjects were deemed unsuitable for participation by investigator, such as uncontrolled infection and conditions that interfere with wound healing.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection; Wounds and Injuries; Infertility

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Study Officials

• Chia-Hao Liu, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Staff

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: July 29, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)