None listed
Conditions
Brief summary
this prospective RCT aims to compare the cosmetic outcomes of hatchet flaps versus conventional transposition flaps for reconstruction of small (1.5–5.0 cm) facial soft-tissue defects. The hatchet flap, a rotation-advancement flap aligned along relaxed skin tension lines with a back-cut, is hypothesized to provide superior tension redistribution and aesthetic scarring. The study focuses on the South Asian population (Fitzpatrick skin types III–V), a group in which such comparative data are currently lacking. Sixty patients will be analyzed using the Patient and Observer Scar Assessment Scale (POSAS) at three months post-operatively. Results are expected to clarify whether the hatchet flap offers a statistically and cosmetically superior alternative to traditional transposition flaps in this skin type.
Interventions
After taking ethical approval from the Institutional Review Board, 60 patients, who will undergo facial soft-tissue reconstruction with either a Hatchet flap (n=30) or a Transposition flap (n=30) will be recruited in the study, fulfilling the inclusion criteria. Sample size will be n=30 in each group, After recruitment, informed written consent will be taken from all patients. The details of surgery and post-operative follow-up will be explained to patients and their attendants.
In Group A, the
After taking ethical approval from the Institutional Review Board, 60 patients, who will undergo facial soft-tissue reconstruction with either a Hatchet flap (n=30) or a Transposition flap (n=30) will be recruited in the study, fulfilling the inclusion criteria. Sample size will be n=30 in each group, After recruitment, informed written consent will be taken from all patients. The details of surgery and post-operative follow-up will be explained to patients and their attendants. In Group A, the hatchet flap will be done by consultant plastic surgeons with at least 5 years experience in plastic surgery. Primary investigator will directly observe the intervention. Consultants will be requested to do wound closure in two layers; deep layer with polyglactin suture and skin closure with polypropylene interrupted sutures. Expected duration of surgery will be one hour. Steri-strips will be applied. Stitches will be removed on 7th day.
Sponsors
Minahil Saifullah, King Edward Medical University, Lahore, Pakistan.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Defects on face resulting from non-melanotic tumour excision or trauma 2. Size of defect ranging from 1.5 to 5.0 cm 3. South Asian skin type: Fitzpatrick skin types 3, 4 and 5. Defined as follows:- Skin type 3:- sometimes burns, always tans, medium complexion. Skin type 4:- rarely burns, always tans, olive complexion. Skin type 5:- never burns, always tans, medium brown complexion. This will be determined by observation of 3 consultant plastic surgeons and decision of majority (2 out of 3) will be considered final.
Exclusion criteria
1. Comorbidities compounding the healing process 2. Allergy to local anesthesia
Outcome results
None listed