NCT02737943

Brief Summary

40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment (MEBO). Intervention: Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the healing speed and re-epithelization process of skin graft donor and recipient sites. Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections, rate of complications, total treatment costs and its effect on improving pain alleviation. Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics \& analgesics) Estimated Time to Complete 5 months

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

April 5, 2016

Last Update Submit

January 25, 2019

Conditions

Burns

Keywords

Skin graftBurnMEBOWound dressingWound careRaw Area

Outcome Measures

Primary Outcomes (1)

  • Wound Healing Assessment

    Standardized digital photographs will be taken of each site at the time of wound inspection, visit 1 and visit 2 then a plastic surgeon and a plastic resident will assessed the healing process blindly. These observers independently will rate the extent of re -epithelialization in each image as none, less than 50%, more than 50% but not complete, or complete. A numeric score was given to each rating as follows: No re epithelialization=0, less than 50%=1, more than 50%=2, and complete=3. Hence, a higher score indicated a greater estimated extent of re -epithelialization.

    1 month

Secondary Outcomes (6)

  • Recovery Time

    1 month

  • Rate of Infections

    2 weeks

  • Pain Assessment

    2 weeks

  • Total Treatment Costs

    1 month

  • Rate of Complications

    1 week

  • +1 more secondary outcomes

Study Arms (2)

Arm1 Mebo

EXPERIMENTAL

20 : receiving Moist Exposed Burn Ointment (MEBO) at sites of donor graft and recipient at time of operation and in dressing

Drug: Moist Exposed Burn Ointment (MEBO)

Arm2 Placebo

PLACEBO COMPARATOR

20 : receiving Standard cream Zagazig University Hospital (Antibiotics \& analgesics)

Drug: Zagazig

Interventions

Moist Exposed Burn Ointment (MEBO)DRUG

is a registered USA patented formulation since 1995. MEBO is pure herbal, natural in origin, containing beta-sitosterol phellodendron amurense, scutellaria baicalensis, coptis chinensis, pheretima aspergillum, Beeswax and sesame oil. 15, 19 The pharmacological effects are attributable to: beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensis, Beeswax and sesame oil.

Also known as: MEBO cream
Arm1 Mebo
ZagazigDRUG

Standard care is an antibiotic ointment in combination of analgesic for relief of pain.

Also known as: Antibiotic & Analgesic
Arm2 Placebo

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who will be managed using split-thickness skin graft.
  • Donor skin grafts are harvested from a site in the thigh (a minimum of 5 x 5-cm total area).
  • Intention for treatment at Zagazig University.
  • Age between 2 \& 60 years.
  • An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian.
  • Compliance with treatment for 3 weeks.
  • Patients of childbearing age must have a negative pregnancy test.

You may not qualify if:

  • Chemical or electrical burns.
  • Patient with concomitant injury of head trauma, inhalation injury, or bone fracture.
  • Pregnant or breast-feeding female.
  • Known or suspected allergies to any of the components of MEBO.
  • Suspicion or presence of active systemic or local cancer or tumor of any kind.
  • Any immune deficiency disorder.
  • Suspected alcohol or drug abuse.
  • Participation in another investigational drug study within 30 days prior to treatment start.
  • If the donor site is less than 5 x 5-cm total area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Alsharkia, 44519, Egypt

RECRUITING

Related Publications (11)

  • Atiyeh BS, Dham R, Kadry M, Abdallah AF, Al-Oteify M, Fathi O, Samir A. Benefit-cost analysis of moist exposed burn ointment. Burns. 2002 Nov;28(7):659-63. doi: 10.1016/s0305-4179(02)00075-x.

    PMID: 12417161BACKGROUND

  • Mabrouk A, Boughdadi NS, Helal HA, Zaki BM, Maher A. Moist occlusive dressing (Aquacel((R)) Ag) versus moist open dressing (MEBO((R))) in the management of partial-thickness facial burns: a comparative study in Ain Shams University. Burns. 2012 May;38(3):396-403. doi: 10.1016/j.burns.2011.09.022. Epub 2011 Nov 17.

    PMID: 22100189BACKGROUND

  • Carayanni VJ, Tsati EG, Spyropoulou GC, Antonopoulou FN, Ioannovich JD. Comparing oil based ointment versus standard practice for the treatment of moderate burns in Greece: a trial based cost effectiveness evaluation. BMC Complement Altern Med. 2011 Dec 1;11:122. doi: 10.1186/1472-6882-11-122.

    PMID: 22132709BACKGROUND

  • Atiyeh BS, Ghanimeh G, Kaddoura IL, Ioannovich J, Al-Amm CA. Split-thickness skin graft donor site dressing: preliminary results of a controlled, clinical comparative study of MEBO and Sofra-Tulle. Ann Plast Surg. 2001 Jan;46(1):87-8. doi: 10.1097/00000637-200101000-00023. No abstract available.

    PMID: 11192048BACKGROUND

  • Spear M, Bailey A. Treatment of skin graft donor sites with a unique transparent absorbent acrylic dressing. Plast Surg Nurs. 2009 Oct-Dec;29(4):194-200; quiz 201-2. doi: 10.1097/PSN.0b013e3181c4cdd9.

    PMID: 20029295BACKGROUND

  • Weber RS, Hankins P, Limitone E, Callender D, Frankenthaler RM, Wolf P, Goepfert H. Split-thickness skin graft donor site management. A randomized prospective trial comparing a hydrophilic polyurethane absorbent foam dressing with a petrolatum gauze dressing. Arch Otolaryngol Head Neck Surg. 1995 Oct;121(10):1145-9. doi: 10.1001/archotol.1995.01890100055009.

    PMID: 7546582BACKGROUND

  • Wiechula R. The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review. Int J Nurs Pract. 2003 Apr;9(2):S9-17. doi: 10.1046/j.1322-7114.2003.00417.x.

    PMID: 12694482BACKGROUND

  • Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.

    PMID: 11525858BACKGROUND

  • Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.

    PMID: 15269581BACKGROUND

  • Hormbrey E, Pandya A, Giele H. Adhesive retention dressings are more comfortable than alginate dressings on split-skin-graft donor sites. Br J Plast Surg. 2003 Jul;56(5):498-503. doi: 10.1016/s0007-1226(03)00195-4.

    PMID: 12890465BACKGROUND

  • Giele H, Tong A, Huddleston S. Adhesive retention dressings are more comfortable than alginate dressings on split skin graft donor sites--a randomised controlled trial. Ann R Coll Surg Engl. 2001 Nov;83(6):431-4.

    PMID: 11777142BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

moist exposed burn ointmentAnti-Bacterial AgentsAnalgesics

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsCentral Nervous System Agents

Study Officials

  • Muhammad H Abdel-All, Professor

    Zagazig University

    STUDY DIRECTOR

Central Study Contacts

Mohammad S Alsabbahi, As. Lecturer

CONTACT

+201092007426doctor.sabbahi@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 14, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)