KeloidPhase 4NCT03239964
Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence
A Phase 4 study testing Dexamethasone and surgical excision in people with Keloid, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent keloid at site of surgical scar. One group will undergo surgical excision of keloid. The other group will have combined surgical excision of keloid and single intralesional dexamethasone injection at edges of wound.All… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Keloid
- What is being tested?
- Dexamethasone and surgical excision
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2016to 24 Jan 2018
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Documented keloids of pfannenstiel incision or midline subumbilical incision of one to five years duration.
- Previous treatment of keloid and recurrence.
- Patient complaint of cosmetic disfiguring, pain or pruritis at site of scar.
Who cannot join
- Scar <1 years' duration
- Scar extending beyond the limits of the original lesion
- postburn keloids
- Diabetes Mellitus, anaemia (haemoglobin level <10mg/dL), malignancy, malnutrition.
- local inflammation at site of scar
- Allergy to dexamethasone.
- Immunocompromized patients or patients on chronic steroid treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.
Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent keloid at site of surgical scar. One group will undergo surgical excision of keloid. The other group will have combined surgical excision of keloid and single intralesional dexamethasone injection at edges of wound.All patients were reviewed once per month for 6 months for evidence of recurrence
Read the detailed description
One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital for caesarean section, will be enrolled in this randomized clinical trial after approval by the local ethical health committee. A written informed consent will be obtained from each participant after full explanation of the procedure.
Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of the keloid is performed and minimal undermining followed by the usual steps of caesarean section. Primary closure of the wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. In 73 patients (group B), the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.
For all patients, the wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed.
Postoperative medications are given to all patients in the form of analgesics and antibiotics as routinely given at the hospital. All patients were advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) were used in any of the patients. All patients were reviewed once per month for 6 months.
- Conditions
- Keloid
- Being tested
- Dexamethasone, surgical excision
- Keywords
- recurrent keloid, surgical excision, steroids injection
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.
surgical excisionOther
total extralesional surgical excision of the keloid is performed and minimal undermining
| Study group | Role | What they receive |
|---|---|---|
| excision only group | Active comparator | Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section. Primary closure of wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. The wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed.
Routine postoperative medications are given to all patients. They are advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) are used in any of the patients. All patients are reviewed once per month for 6 months. Receives: Other: surgical excision |
| excision and injection group | Active comparator | Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section and primary closure of the wound in layers. A running subcuticular prolene 2/0 stitch is used to suture skin.In 73 patients (group B), wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue. The wound is painted with betadine and sealed until postoperative day 14 to remove the subcuticular stitch.
Routine postoperative medications are given, avoidance of direct sun exposure for one month,No postoperative applications as compression, steroid injections, etc. All patients are reviewed once per month for 6 months. Receives: Drug: Dexamethasone; Other: surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrent lesions
same/smaller/larger than pretreatment lesion
Measured: 6 months
Secondary outcomes (5)
Number of participantsc with pruritis
itching sensation at the site of wound
Measured: 6 months
Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
redness or coloured pigmentation at wound site
Measured: 6 months
Number of participants with burning sensation
feel burn at wound site
Measured: 6 months
Number of participants with wound dehiscence(complete)
area of gaping of wound that requires secondary sutures
Measured: 6 months
Number of participants with wound dehiscence(partial)
area of gaping of wound that requires frequent dressings only
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start10 Aug 2016
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira S Dieb, Kasr El Aini Hospital
- Investigators
- Amira Dieb, MD, Principal investigator, KasrAlainiH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239964
- Sponsor's protocol ID
- 88765510
- Status last verified
- Nov 2018
- First submitted
- 29 Jul 2017
- Last updated
- 5 Nov 2018
- Results posted
- 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 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03239964
- Acronym / sponsor ID
- 88765510
- Conditions
- Keloid
- Keywords
- recurrent keloid, surgical excision, steroids injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 4 Aug 2017 (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.
Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent keloid at site of surgical scar. One group will undergo surgical excision of keloid. The other group will have combined surgical excision of keloid and single intralesional dexamethasone injection at edges of wound.All patients were reviewed once per month for 6 months for evidence of recurrence
Detailed description
One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital for caesarean section, will be enrolled in this randomized clinical trial after approval by the local ethical health committee. A written informed consent will be obtained from each participant after full explanation of the procedure.
Under general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of the keloid is performed and minimal undermining followed by the usual steps of caesarean section. Primary closure of the wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. In 73 patients (group B), the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.
For all patients, the wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed.
Postoperative medications are given to all patients in the form of analgesics and antibiotics as routinely given at the hospital. All patients were advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) were used in any of the patients. All patients were reviewed once per month for 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| excision only group | Active comparator | Other: surgical excisionUnder general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section. Primary closure of wound in layers is achieved in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A of 73 patients will not receive further injection. The wound is painted with betadine and sealed until postoperative day 14, at which time the subcuticular stitch is removed. Routine postoperative medications are given to all patients. They are advised to avoid direct sun exposure for the following month. No postoperative applications (eg, compression, steroid injections, etc) are used in any of the patients. All patients are reviewed once per month for 6 months. |
| excision and injection group | Active comparator | Drug: Dexamethasone, Other: surgical excisionUnder general or spinal anaesthesia done routinely during caesarean section, total extralesional surgical excision of keloid is performed and minimal undermining followed by usual steps of caesarean section and primary closure of the wound in layers. A running subcuticular prolene 2/0 stitch is used to suture skin.In 73 patients (group B), wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue. The wound is painted with betadine and sealed until postoperative day 14 to remove the subcuticular stitch. Routine postoperative medications are given, avoidance of direct sun exposure for one month,No postoperative applications as compression, steroid injections, etc. All patients are reviewed once per month for 6 months. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Documented keloids of pfannenstiel incision or midline subumbilical incision of one to five years duration.
- Previous treatment of keloid and recurrence.
- Patient complaint of cosmetic disfiguring, pain or pruritis at site of scar.
Key exclusion criteria (7 listed)
- Scar <1 years' duration
- Scar extending beyond the limits of the original lesion
- postburn keloids
- Diabetes Mellitus, anaemia (haemoglobin level <10mg/dL), malignancy, malnutrition.
- local inflammation at site of scar
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 |
|---|---|---|
| Dexamethasonethe wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue. | Drug | excision and injection group |
| surgical excisiontotal extralesional surgical excision of the keloid is performed and minimal undermining | Other | excision and injection group, excision only group |
Primary outcome
Number of participants with recurrent lesions
Time frame: 6 months
same/smaller/larger than pretreatment lesion
5 secondary outcomes
Number of participantsc with pruritis
Time frame: 6 months
Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
Time frame: 6 months
Number of participants with burning sensation
Time frame: 6 months
Number of participants with wound dehiscence(complete)
Time frame: 6 months
Number of participants with wound dehiscence(partial)
Time frame: 6 months
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 5 Nov 2018.
- 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.
Amira Dieb, MD principal investigator
KasrAlainiH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and surgical excision in people with Keloid, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 7 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 5 Nov 2018. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with recurrent lesions (time frame: 6 months). 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 5 Nov 2018.