Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Comparison of Outcomes of Plantar vs Groin Full-Thickness Skin Graft for Correction of Congenital Syndactyly of Hand

10 giugno 2026 aggiornato da: Kainat usman, Sheikh Zayed Medical College

Congenital syndactyly is a condition present at birth in which two or more fingers are joined together. Surgical correction was performed to separate the fingers, improve hand appearance, and support better hand function. After separation of the fingers, a skin graft is often needed to cover the skin defect created during surgery. Full-thickness skin grafts may be taken from different donor sites. The groin has commonly been used as a donor site, but groin skin may differ from hand skin in color and texture. The plantar area of the foot has been considered as an alternative donor site because it may provide better color and texture matching and the donor scar is usually less visible.

This randomized controlled study compared the outcomes of plantar full-thickness skin grafts with groin full-thickness skin grafts in children who underwent surgical correction for congenital simple complete syndactyly of the hand. The study was conducted in the Department of Plastic Surgery, Sheikh Zayed Hospital, Rahim Yar Khan. Children aged 1 to 10 years with congenital simple complete syndactyly who required surgical correction with skin grafting were enrolled after written informed consent was obtained from their guardians. Children with complex syndactyly, associated congenital syndromes, infections, skin diseases, previous surgery on the affected hand, or missing postoperative photographs were not included.

The participants were assigned to one of two treatment groups by sealed opaque envelopes using a lottery method. One group received a plantar full-thickness skin graft, while the other group received a groin full-thickness skin graft. All operations were performed by a consultant plastic surgeon according to standard surgical practice. Postoperative follow-up was carried out at 2 weeks, 4 weeks, and 6 weeks after surgery.

The main purpose of the study was to compare postoperative complications between the two graft methods. These complications included scar contracture, web creep, donor-site hypertrophic scarring, and delayed healing. Scar contracture referred to tightening or shrinking of the graft or surrounding tissues that could limit finger movement or cause deformity. Web creep referred to distal migration of the reconstructed web space after surgery. Donor-site complications included raised or thickened scarring and delayed wound healing. These outcomes were assessed during follow-up visits by a consultant plastic surgeon who was blinded to the treatment group.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Punjab Province
      • Rahim Yar Khan, Punjab Province, Pakistan, 64200
        • Sheikh Zayed Medical college/hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients aged 1 to 10 years of either gender with congenital simple complete syndactyly
  • Cases requiring surgical correction with skin grafting.
  • Patients with no prior surgical intervention on the affected hand.

Exclusion Criteria:

  • Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
  • Patients with missing postoperative photographs.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group I - Plantar Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a plantar full-thickness skin graft. The graft was harvested from the plantar surface of the foot and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the plantar surface of the foot and applied to the recipient defect after separation of the fused fingers.
Comparatore attivo: Group II - Groin Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a groin full-thickness skin graft. The graft was harvested from the groin region and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the groin region and applied to the recipient defect after separation of the fused fingers.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency of Scar Contracture
Lasso di tempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Scar contracture was assessed as abnormal tightening or shrinkage of the graft or surrounding tissue after syndactyly correction, resulting in visible tightness, deformity, or limitation of finger movement at the surgical site. It was graded as none, mild, moderate, or severe according to clinical examination of range of motion and visible contracture. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Web Creep
Lasso di tempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Web creep was assessed as distal migration of the reconstructed web space beyond the expected anatomical location after syndactyly correction. It was evaluated by visual inspection and measurement from the metacarpophalangeal joint crease to the web apex. Web creep was categorized as absent, less than 5 mm, 5 to 10 mm, or more than 10 mm. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Donor-Site Hypertrophic Scarring
Lasso di tempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Donor-site hypertrophic scarring was assessed as a raised, thickened, erythematous, or pruritic scar confined within the boundaries of the original donor-site wound. It was evaluated through visual and tactile examination of the donor site. The outcome was recorded as present or absent. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Delayed Healing
Lasso di tempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Delayed healing was assessed as failure of complete epithelialization of the graft or donor-site wound within more than 3 weeks after surgery, or the presence of wound dehiscence, infection, necrosis, or persistent exudate. The outcome was recorded according to clinical wound examination. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Aesthetic Outcome Score
Lasso di tempo: 6 weeks after surgery
The aesthetic outcome of the operated hand was assessed using a 1 to 10 score by a consultant plastic surgeon blinded to the treatment group. The score was based on cosmetic appearance, including scar quality, web space appearance, symmetry, and overall visual restoration of the hand. Lower scores indicated poor aesthetic outcome, while higher scores indicated excellent cosmetic outcome.
6 weeks after surgery
Healing Time
Lasso di tempo: Up to 6 weeks after surgery
Healing time was recorded as the total number of days required for complete epithelialization of the graft and donor-site wounds after surgery.
Up to 6 weeks after surgery
Guardian Satisfaction Score
Lasso di tempo: 6 weeks after surgery
Guardian satisfaction with the surgical outcome was recorded using a visual analogue scale ranging from 1 to 10. Lower scores indicated poor satisfaction, while higher scores indicated greater satisfaction with the overall surgical outcome, including appearance, function, and healing of the operated hand.
6 weeks after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Wardah Rehmat, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2025

Completamento primario (Effettivo)

31 dicembre 2025

Completamento dello studio (Effettivo)

31 dicembre 2025

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi