Surgical Wound HealingNCT01724255
Optimal Time for Staple/Dressing Removal
An observational study of Surgical Wound Healing and Surgical Wound Infection, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients: 1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Surgical Wound Healing, Surgical Wound Infection, Patient Satisfaction
- What is being tested?
- questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Dec 2014
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients undergoing a cesarean section at our facility
Who may be able to join
- patients undergoing a cesarean section at our facility
Who cannot join
- patients lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing
The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
- staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
- staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)7
Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.
- Being tested
- questionnaire
- Keywords
- Caesarian section, Surgical Wound
- Medical subject headings
- Surgical Wound Infection, Patient Satisfaction, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| staple removal day 4 dressing removal day 1 | early staple removal and early dressing removal Receives: Other: questionnaire | |
| staple removal day 4 dressing removal day 4 | early staple removal and day 4 dressing removal Receives: Other: questionnaire | |
| staple removal day 7, dressing removal day 1 | late staple removal and early dressing removal Receives: Other: questionnaire | |
| staple removal day 7, dressing removal day 7 | late staple removal and late dressing removal Receives: Other: questionnaire | |
| staple removal day 7, dressing removal day 4 | late staple removal and day 4 dressing removal Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Wound infection and complications
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound HealingStudies of the same condition, open and under way.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner-Celnikier, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724255
- Sponsor's protocol ID
- StapleDressingRemoval-HMO-CTIL
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinemann N, Solnica A, Abdelkader R, Gutman J, Nalbandian N, Raizman E, Hochner-Celnikier D. Timing of staples and dressing removal after cesarean delivery (the SCARR study). Int J Gynaecol Obstet. 2019 Mar;144(3):283-289. doi: 10.1002/ijgo.12757. Epub 2019 Jan 11.
PubMed 30582610
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing
- ClinicalTrials.gov ID
- NCT01724255
- Acronym / sponsor ID
- StapleDressingRemoval-HMO-CTIL
- Keywords
- Caesarian section, Surgical Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2012 (estimated)
- 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 medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
- staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
- staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
- staple removal on POD 4 and dressing removal on Post Operative Day (POD)7
Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| staple removal day 4 dressing removal day 1 | – | Other: questionnaireearly staple removal and early dressing removal |
| staple removal day 4 dressing removal day 4 | – | Other: questionnaireearly staple removal and day 4 dressing removal |
| staple removal day 7, dressing removal day 1 | – | Other: questionnairelate staple removal and early dressing removal |
| staple removal day 7, dressing removal day 7 | – | Other: questionnairelate staple removal and late dressing removal |
| staple removal day 7, dressing removal day 4 | – | Other: questionnairelate staple removal and day 4 dressing removal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients undergoing a cesarean section at our facility
Key inclusion criteria (1 listed)
- patients undergoing a cesarean section at our facility
Key exclusion criteria (1 listed)
- patients lost to follow up
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 |
|---|---|---|
| questionnaire | Other | staple removal day 4 dressing removal day 1, staple removal day 4 dressing removal day 4, staple removal day 7, dressing removal day 1, staple removal day 7, dressing removal day 4, staple removal day 7, dressing removal day 7 |
Primary outcome
Incidence of Wound infection and complications
Time frame: 6 weeks
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 28 Jul 2015.
- Derived from this study: PubMed 30582610Heinemann N, Solnica A, Abdelkader R, Gutman J, Nalbandian N, Raizman E, Hochner-Celnikier D. Timing of staples and dressing removal after cesarean delivery (the SCARR study). Int J Gynaecol Obstet. 2019 Mar;144(3):283-289. doi: 10.1002/ijgo.12757. Epub 2019 Jan 11.
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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.
Drorith Hochner-Celnikier, MD principal investigator
Hadassah Medical Organization
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 Surgical Wound Healing and Surgical Wound Infection, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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 28 Jul 2015. 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 Israel. 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?
Incidence of Wound infection and complications (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724255, which also lists 1 linked publication.
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 28 Jul 2015.