Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202510826301945 Date of Registration: 31/10/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title “A study using a local skin flap from the back of the hand to reconstruct fused fingers.”
Official scientific title “The use of dorsal metacarpal artery perforator flap for finger web syndactyly reconstruction: A prospective clinical study.”
Brief summary describing the background and objectives of the trial Finger web syndactyly, whether congenital or post-burn, causes fusion between adjacent fingers, leading to limited hand function and an unsatisfactory appearance. Traditional correction using skin grafts often results in complications such as contracture, color mismatch, and donor site problems. Recently, local flaps based on dorsal metacarpal artery perforators have shown promising outcomes due to their good vascularity, thin texture, and color match. This prospective clinical study aims to evaluate the effectiveness and safety of using the dorsal metacarpal artery perforator flap for reconstructing finger web syndactyly. The study will assess functional and aesthetic outcomes, flap viability, complication rates, and patient satisfaction to determine whether this flap provides a superior alternative to conventional skin grafting in web space reconstruction.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/11/2025
Actual trial start date
Anticipated date of last follow up 30/04/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 23
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Not applicable (no prior publication yet)
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dorsal metacarpal artery perforator flap reconstruction Not applicable (single surgical procedure performed once per patient). Single surgical session with postoperative follow-up for 6 months. Surgical reconstruction of finger web syndactyly using a dorsal metacarpal artery perforator flap. Under regional or general anesthesia, the web contracture is released and a dorsal perforator flap is designed over the dorsum of the hand, centered on the dorsal metacarpal artery perforator. The flap is elevated as an island flap, transposed to reconstruct the web space, and inset without tension. The donor site is closed primarily or covered with a split-thickness skin graft if needed. Postoperatively, the hand is dressed and splinted in a functional position, and patients are followed for 6 months to assess flap viability, web depth, functional recovery, and aesthetic outcomes. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with finger web syndactyly (congenital or postburn). • Age: Any age group suitable for surgical intervention. • Patients requiring surgical reconstruction of the web space using local flaps. • Patients with good general health and adequate vascularity of the hand. • Patients who provided informed consent for participation in the study. • Patients with compromised vascularity of the hand or fingers. • Patients with uncontrolled systemic diseases (e.g. uncontrolled diabetes, severe cardiac conditions) contraindicating surgery. • Patients with active local infection at the surgical site. • Patients who refused to participate or did not provide informed consent. • Patients with previous failed flap surgeries at the same site affecting local flap options. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 3 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/10/2025 Institutional Review Board of Faculty of Medicine Assiut university
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Assiut university Egypt, Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Web Depth Adequacy: o Measurement: Linear depth of the reconstructed web space, measured from the fingertip level to the base of the web (commissure), using a sterile caliper or ruler. o Comparison: Matched against the contralateral or adjacent normal web in the same hand. o Data Type: Quantitative (millimeters). o Statistical Use: Mean difference between reconstructed and normal web depth to be analyzed using paired t-test. 3 month
Secondary Outcome Functional Outcome: o Measurement: Active range of motion (ROM) of the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of the affected digits. o Tool: Goniometer. o Timing: Assessed preoperatively and at final follow-up (e.g., 6 months postoperatively). o Data Type: Quantitative (degrees of motion). o Statistical Use: Paired t-test will be applied to compare pre- and postoperative ROM values for significance. 6 months
Secondary Outcome Flap Viability: Categorised as complete survival, partial necrosis, or total flap loss. During hospital stay and at each postoperative follow-up visit up to 2 weeks.
Secondary Outcome Complication Rates: Including infection, hematoma, wound dehiscence, donor site morbidity, and need for revision surgery Throughout the postoperative period up to 6 months follow-up.
Secondary Outcome Aesthetic Outcome: Evaluated by surgeon and patient/parent satisfaction using a validated Likert scale or aesthetic scoring system At final follow-up, 6 months postoperatively.
Secondary Outcome Patient/Parent Satisfaction: Overall satisfaction with hand appearance and function postoperatively. At final follow-up, 6 months postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Plastic and Reconstructive Surgery Department Assiut University hospitals Assiut University Hospitals, El-Gamaa Street, Assiut, Egypt Assiut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Assiut University El-Gamaa Street, Faculty of Medicine, Assiut University, Assiut, Egypt Assuit 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Assiut University Egypt El-Gamaa Street Assiut University Campus Assiut Egypt Assuit 71515 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nourhan Abdelaziz Ahmed Ali Norhan.17289715@med.aun.edu.eg 01114531678 Assiut University Hospital, Faculty of Medicine, Assiut University
City Postal code Country Position/Affiliation
Assuit 71515 Egypt Resident in Department of Plastic and Reconstructive Surgery
Role Name Email Phone Street address
Public Enquiries Nourhan Abdelaziz Ahmed Ali Norhan.17289715@med.aun.edu.eg 01114531678 Assiut University Hospital, Faculty of Medicine, Assiut University
City Postal code Country Position/Affiliation
Assuit 71515 Egypt Resident
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa Abd Elmoniem Elyounsi Mohamed_elyounsi@aun.edu.eg +201005787522 Assiut University Hospital, Assiut, Egypt
City Postal code Country Position/Affiliation
Assuit 71515 Egypt Assistant Professor of Plastic and Reconstructive Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (including demographic details, operative data, outcome measures, and follow-up results) that underlie the results reported in the final publication will be made available. The shared data will not include any personal identifiers such as names, contact details, or hospital record numbers. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be accessible beginning 12 months after publication of the study results and for up to 5 years thereafter. Requests for data access should be submitted via email to the principal investigator at: Norhan.17289715@med.aun.edu.eg Access will be granted for research purposes that align with the aims of improving surgical outcomes and patient care in hand reconstruction.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not publicly No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information