Cesarean SectionNCT06558240
To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
An observational study of Cesarean Section and Surgical Wound, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Surgical Wound, Surgical Wound Infection
- What is being tested?
- HERADERM Hydrogel Wound Dressing (Sterile)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects going to have cesarean section in Taipei Veterans General Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- HERADERM Hydrogel Wound Dressing (Sterile)
- Keywords
- cesarean section, wound healing, HERADERM Hydrogel Wound Dressing (Sterile), surgical site infection, wound care
- Medical subject headings
- Surgical Wound, Surgical Wound Infection, Wounds and Injuries, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: HERADERM Hydrogel Wound Dressing (Sterile) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The incidence of allergic reaction related to the experimental dressings will be recorded. The final wound check will be performed by the surgeon at 11 days postoperatively.
Measured: Within 11 days after surgery
Intensity of pain during dressing removal
Pain intensity is assessed by Numerical Rating Scale (NRS). Numerical Rating Scale was a 11-point scale on which 0 represented "no pain" and 10 represented the" worst pain ever".
Measured: Assessing on post-operative day 2, 4 & 11
Incidence of adverse events
The incidence of postoperative adverse events related to the experimental dressings will be recorded.
Measured: Within 11 days after surgery
Number of dressing change
Subjects will take home 2 pieces of experimental dressings and change by themselves. Number of dressing change will be recorded at 11 days postoperatively.
Measured: Within 11 days after surgery
Satisfaction survey
Subjects' and caregivers' satisfaction survey regarding user experience quantified with the use of a 5-grade scale with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.
Measured: Assessing on post-operative day 2, 4 & 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start29 Jul 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chia-Hao Liu, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chia-Hao Liu, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558240
- Sponsor's protocol ID
- 2024-08-023AC
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
- ClinicalTrials.gov ID
- NCT06558240
- Acronym / sponsor ID
- 2024-08-023AC
- Keywords
- cesarean section, wound healing, HERADERM Hydrogel Wound Dressing (Sterile), surgical site infection, wound care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: HERADERM Hydrogel Wound Dressing (Sterile) | – | Device: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects going to have cesarean section in Taipei Veterans General Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERADERM Hydrogel Wound Dressing (Sterile)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. | Device | Experimental: HERADERM Hydrogel Wound Dressing (Sterile) |
Primary outcome
REEDA scale
Time frame: Assessing on post-operative day 2, 4 & 11
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.
Percentage of surgical wound infection
Time frame: Assessing on post-operative day 2, 4 & 11 if there are any surgical site 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.
5 secondary outcomes
Percentage of allergic reaction to experimental dressings
Time frame: Within 11 days after surgery
Intensity of pain during dressing removal
Time frame: Assessing on post-operative day 2, 4 & 11
Incidence of adverse events
Time frame: Within 11 days after surgery
Number of dressing change
Time frame: Within 11 days after surgery
Satisfaction survey
Time frame: Assessing on post-operative day 2, 4 & 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hao Liu, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Surgical Wound, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REEDA scale (time frame: Assessing on post-operative day 2, 4 & 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.