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Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence

Primary Purpose

Keloid

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
surgical excision
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keloid focused on measuring recurrent keloid, surgical excision, steroids injection

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.

Sites / Locations

  • KasralainiH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

excision only group

excision and injection group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with recurrent lesions
same/smaller/larger than pretreatment lesion

Secondary Outcome Measures

Number of participantsc with pruritis
itching sensation at the site of wound
Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
redness or coloured pigmentation at wound site
Number of participants with burning sensation
feel burn at wound site
Number of participants with wound dehiscence(complete)
area of gaping of wound that requires secondary sutures
Number of participants with wound dehiscence(partial)
area of gaping of wound that requires frequent dressings only

Full Information

First Posted
July 29, 2017
Last Updated
November 1, 2018
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03239964
Brief Title
Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence
Official Title
Combined Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence.A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
recurrent keloid, surgical excision, steroids injection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
excision only group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
excision and injection group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
surgical excision
Intervention Description
total extralesional surgical excision of the keloid is performed and minimal undermining
Primary Outcome Measure Information:
Title
Number of participants with recurrent lesions
Description
same/smaller/larger than pretreatment lesion
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participantsc with pruritis
Description
itching sensation at the site of wound
Time Frame
6 months
Title
Number of participants with residual postinflammatory hyperpigmentation -burning sensation -wound dehiscence
Description
redness or coloured pigmentation at wound site
Time Frame
6 months
Title
Number of participants with burning sensation
Description
feel burn at wound site
Time Frame
6 months
Title
Number of participants with wound dehiscence(complete)
Description
area of gaping of wound that requires secondary sutures
Time Frame
6 months
Title
Number of participants with wound dehiscence(partial)
Description
area of gaping of wound that requires frequent dressings only
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Dieb, MD
Organizational Affiliation
KasrAlainiH
Official's Role
Principal Investigator
Facility Information:
Facility Name
KasralainiH
City
Cairo
ZIP/Postal Code
11956
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence

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